MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIFIX 10CMX10M CTN 1; TAPE AND BANDAGE, ADHESIVE

Catalog Number	66000041
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that in opsite flexifix 10cm x 10cm, ctn 1, a decoloration in the protective backing was found, also the tape appears more flimsy and edges curl causing lifting and in both occasions leaking of urostomy.There was no changes in urostomy output, the procedure was successfully completed using the same device.No patient injury, delay or other complications were reported.
Additional Manufacturer Narrative
We have now concluded our investigation for the complaint received.A review of the batch manufacturing records could not be performed as no lot number was provided, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.The complaint history file contains further instances/ related events of the reported event.The device was used for treatment.The returned sample was evaluated.No issues were identified.The returned samples appeared to be within specification and adhered to skin satisfactorily.The reported issue may be attributed to application or maintenance techniques.We have not been able to confirm a relationship between the event and the device.The investigation has been closed as no device problem found.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.

• Brand Name: OPSITE FLEXIFIX 10CMX10M CTN 1
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10511614
• Report Number: 8043484-2020-02802
• Device Sequence Number: 1217410
• Product Code: KGX
• UDI-Device Identifier: 05000223411473
• UDI-Public: 5000223411473
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 01/19/2021

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: 66000041
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1