MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN OPSITE POST OP; TAPE AND BANDAGE, ADHESIVE

Catalog Number UNKN05004802

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Impaired Healing (2378); Tissue Breakdown (2681); Localized Skin Lesion (4542)

Event Date 05/07/2021

Event Type  Injury  

Event Description

It was reported that, after treatment with opsite post-op, one patient was not satisfied with the prevention of maceration.The patient stated that the wound remained macerated after 7 days.It was not reported if/how the adverse event was treated.This incident was noticed in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing outcomes were gathered; therefore, additional information is not known and it is not possible to collect it.

Manufacturer Narrative

H10: the device, used in treatment, was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable causes may include criteria of wound, application of product, or time left on the patient.No lot/serial number has been provided therefore a review of manufacturing records is not possible.A complaint history review found further instances of the reported event.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

Event Description

It was reported that, after treatment with opsite post-op, one patient was not satisfied with the prevention of maceration.The patient stated that the wound remained macerated after 7 days.It was not reported if/how the adverse event was treated.This incident was noticed in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing outcomes were gathered; therefore, additional information is not known and it is not possible to collect it.

• Brand Name: UNKN OPSITE POST OP
• 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
• MDR Report Key: 11891153
• MDR Text Key: 252882036
• Report Number: 8043484-2021-01228
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/20/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKN05004802
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/10/2021
• Initial Date FDA Received: 05/26/2021
• Supplement Dates Manufacturer Received: 09/14/2021
• Supplement Dates FDA Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention