Testing of device from same lot batch returned from user (Q61144): Difference between revisions
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A investigação empregou testes empíricos relevantes do dispositivo do mesmo lote ou igual ao do dispositivo suspeito no evento adverso relatado, a fim de apoiar a identificação de possíveis causas para o evento adverso. O dispositivo foi devolvido pelo usuário. Testes relevantes normalmente são baseados em métodos de teste usados para avaliar a segurança e o desempenho, conforme descrito nos padrões relevantes mais recentes. | |||
| description / en | description / en | ||
The investigation employed relevant empirical testing of the device of the same lot or batch as that of the suspected device in the reported adverse event in order to support the identification of possible causes for the adverse event. The device was returned from the user. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards. | |||
Revision as of 08:38, 14 August 2026
The investigation employed relevant empirical testing of the device of the same lot or batch as that of the suspected device in the reported adverse event in order to support the identification of possible causes for the adverse event. The device was returned from the user. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.
| Language | Label | Description | Also known as |
|---|---|---|---|
| default for all languages | XE4S0 |
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| English | Testing of device from same lot batch returned from user |
The investigation employed relevant empirical testing of the device of the same lot or batch as that of the suspected device in the reported adverse event in order to support the identification of possible causes for the adverse event. The device was returned from the user. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards. |
