MAUDE Adverse Event Report: CONVATEC INC AQUACEL AG FOAM; DRESSING, WOUND, DRUG

Model Number	420805
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Occupation: retailer/dealer/distributor.Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).
Event or Problem Description
It was reported black spots were present on the dressing.Photos depicting the reported complaint issue were provided by the complainant.
Additional Manufacturer Narrative
Additional information - (b)(6).Additional information - general hospital branch manager.A batch record review indicates no discrepancies.Device history records and retain dressings for lot # 2577728 were examined.No discrepancies, non ¿ conformance or deviations for raw material, manufacturing, packaging or sterilization processes were documented.All raw materials used to produce lot # 2577728, met specifications.All work in progress and finished goods met specifications.The discoloration seen in the photographs provided by the customer appears to be the result of exposure to ultra violet (uv) light or direct sunlight.A retain dressing from lot # 2577728, was removed from its pouch on 08/21/2018 and displayed no signs of discoloration or black spots on the ag hydrofiber.There is not enough evidence to attribute the black spots seen on the dressing in the customer photograph to the manufacturing or packaging process.The discoloration is cosmetic, and has not impact on product performance, safety or efficacy.Customers are advised to store the product in its protective packaging (the carton) and keep it away from sunlight.No further actions are required at this time and the investigation will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Reporting site: (b)(4).Third party manufacturing site: (b)(4).
Event or Problem Description
No further action required by medical evaluators.Medical reviewer edits needed.

• Brand Name: AQUACEL AG FOAM
• Common Device Name: DRESSING, WOUND, DRUG
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• MDR Report Key: 7781931
• Report Number: 1049092-2018-00368
• Device Sequence Number: 16728558
• Product Code: FRO
• UDI-Device Identifier: 00768455129126
• UDI-Public: 768455129126
• Combination Product (Y/N): N
• PMA/510(K) Number: K123481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Expiration Date: 03/03/2019
• Device Model Number: 420805
• Device Catalogue Number: 420805
• Device Lot Number: 2577728
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1