MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 7.5X7.5CM INT; DRESSING, WOUND, OCCLUSIVE

Catalog Number	66800269
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on removal of the sacral dressing, some particles of silicone remained on the patient's skin surrounding the wound.On removal of the 15x15cm dressing, again, some particles of silicone remained on the patient's skin surrounding the wound.The wounds were both cavities and there was risk the silicone could end up in the wounds.These occurred on different patients, on different wards and different sites within the trust.On opening a new dressing 7.5x7.5cm, parts of the silicone remained on the film cover.It is unknown how many patients are involved.No patient harm reported.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, has not been returned for evaluation.The supplied photo has been reviewed establishing a relationship between the reported event.The root cause has been established as a raw material 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.Complaint history for the reported event has been reviewed, revealing further instances.No further actions are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: ALLEVYN GENTLE BORDER 7.5X7.5CM INT
• Common Device Name: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10311130
• Report Number: 8043484-2020-02152
• Device Sequence Number: 2310363
• Product Code: NAD
• UDI-Device Identifier: 05000223463885
• UDI-Public: 5000223463885
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2020

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 66800269
• Device Lot Number: 201849
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 10/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1