Catalog Number 123625 |
Device Problem
Device Emits Odor (1425)
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Patient Problem
Bacterial Infection (1735)
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Event Date 01/17/2017 |
Event Type
Injury
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Manufacturer Narrative
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On 03/01/2017 - after an indication of customer infection requiring medical treatment on (b)(6), initial report filing.Manufacturing has reviewed the device history record.No out of specification or in process deviations noted.Product was released consistent with all internal specifications.Retained samples did indicate a slight odor.In 2016 - to decrease the odor profile, modification to the in line leaching process, ex dip washing, and odor masking agent were introduced to alleviate the cosmetic odor of the condoms.
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Event Description
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On 03/01/2017 - customer indicated that upon opening the product, the product had a "foul smell".Several other foiled products from the same carton had the same smell.Customer indicated on (b)(6) that partner had an infection and sought medical attention for treatment of infection.
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Manufacturer Narrative
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On 03/01/2017 - after an indication of customer infection requiring medical treatment on (b)(6), initial report filing.Manufacturing has reviewed the device history record.No out of specification or in process deviations noted.Product was released consistent with all internal specifications.Retained samples did indicate a slight odor.In 2016 - to decrease the odor profile, modification to the in line leaching process, ex dip washing, and odor masking agent were introduced to alleviate the cosmetic odor of the condoms.On 05/02/2017: > a review of the device history record indicated that the product was manufactured and processed within specification.No deviations were noted in the production record.> > micro testing of retain samples indicated that samples were within test specifications > protein testing of retained samples were evaluated and are within acceptable limit.> returned samples from customer were inspected and slight odor was detected.> a masking agent along with process enhancements for leaching process in production to lessen this cosmetic aesthetic was cleared under a 510k has since been implemented and is to be shipped by end of june 2017.No other actions to take place.
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Event Description
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On 03/01/2017 - customer indicated that upon opening the product, the product had a "foul smell".Several other foiled products from the same carton had the same smell.Customer indicated on (b)(6) that partner had an infection and sought medical attention for treatment of infection.
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Search Alerts/Recalls
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