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Product complaint # (b)(4).Additional information:
d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Additional information has been requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Where was the foreign material found? (inside the sterile barrier or outside of the sterile barrier?)=>on the drain tube.Please describe the type of foreign matter that was observed.What was the foreign matter¿s appearance? =>black stain what was the texture? unk.Are there any photos of the foreign matter available? no.Is it possible that the foreign material fell into packaging upon opening of device? no.Was the product seal on the foil still intact when the package was opened? yes.Will the device be returned for evaluation? no if yes please return all relevant packaging material?
was the procedure completed without any adverse effect to the patient? another product was used to complete the case.Could you please provide the lot number? unk.Please provide the source or name of person providing answers to follow-up questions: (b)(6).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.No product is available for return.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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