MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 10 X 10CM CTN 10; DRESSING,WOUND,OCCLUSIVE

Catalog Number	66800270
Medical Device Problem Codes	Material Integrity Problem (2978); Separation Problem (4043)
Health Effect - Clinical Codes	Injury (2348); Foreign Body In Patient (2687)
Date of Event	07/02/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during treatment on removal of the plastic cover of the dressing, part of the silicone came away from the foam and was still on the plastic cover.Also, on removal of the same type of dressing from the patients skin, bits of silicone were still on the skin and had to be picked off.An injury was reported.
Additional Manufacturer Narrative
H10.H3, h6: the device, used in treatment, has not been returned for evaluation.We have not been able to establish a relationship between the device and the reported event or determine a root cause on this occasion.It is possible if the product has been stored at a high temperature, this could have contributed to the reported issue.A review of manufacturing records for the reported lot number found no non-conformances or anomalies during production.The device met all specifications upon release into distribution.The complaint history review found further instances of the reported event, currently being monitored, with actions being taken to reduce further instances.Clinical review reports: while using the allevyn gentle border dressing, part of the silicone remained on the cover and on the patient¿s skinned once removed.Per report, the remaining silicone was picked from the patient¿s skin.Although an injury was reported due to the reported silicone offsetting within the dressing, responses to clinical requests were not provided.It is unknown how the event was treated and the patient's current condition is unknown.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device.The associated risk file contains harms, relating to the dressing not adhering.However, as no details of harm have been provided, no further review is deemed necessary.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: ALLEVYN GENTLE BORDER 10 X 10CM CTN 10
• Common Device Name: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull ; UK
• MDR Report Key: 10323848
• Report Number: 8043484-2020-02197
• Device Sequence Number: 16292884
• Product Code: NAD
• UDI-Device Identifier: 05000223463915
• UDI-Public: 5000223463915
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 66800270
• Device Lot Number: 202003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other