MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIFIX GENTLE 10CMX5M; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66801197

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that glue residues were observed on opsite flexifix gentle 10cm x 5m dressings.As this was noticed in a non-surgical environment, there was no patient involvement.

Manufacturer Narrative

B5: updated description h6: updated codes h10: additional information the reported product has not been returned for complaint evaluation, smith and nephew are not able to confirm this complaint.The instructions for use details how the wound contact layer within these dressing can be affected by storage temperature fluctuations.A documentation review has been conducted, confirming previous complaints of this nature, with corrective actions assigned.The complained product was released prior to the actions being initiated.The instructions for use contain comprehensive instructions on the safe operation and use of the device.The risk files mitigate the reported issue with no updates required.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.This investigation is now complete, with no manufacturing problems observed, no additional corrective actions are deemed necessary at this time.

Event Description

It was reported that glue residues were observed on opsite flexifix gentle 10cm x 5m dressings.The issue was observed in a non-surgical environment and no patient harm was reported.

• Brand Name: OPSITE FLEXIFIX GENTLE 10CMX5M
• Type of Device: 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13370992
• MDR Text Key: 284633415
• Report Number: 8043484-2022-00034
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223480400
• UDI-Public: 5000223480400
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2022
• Device Catalogue Number: 66801197
• Device Lot Number: 1392932047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/10/2022
• Initial Date FDA Received: 01/27/2022
• Supplement Dates Manufacturer Received: 01/28/2022
• Supplement Dates FDA Received: 02/02/2022
• Date Device Manufactured: 11/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1