MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE POST OP 9.5X8.5CM CTN 20; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66000709

Device Problems Moisture Damage (1405); Material Integrity Problem (2978)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/18/2020

Event Type  malfunction  

Event Description

It was reported that dressing was applied to patient's heel and while taking a shower dressing became completely saturated, exposing his wound to moisture.No harm or injury reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device used in treatment has been returned and evaluated, with no relationship being established between the event reported.A visual inspection found no defects, the functional evaluation found no faults with adherence or resistance to water.Dressings can come of if incorrectly applied, or if there is anything preventing the dressing from being attached directly to the skin area, the ifu offers full guidance on the application and use.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history file contains further instances of the reported event, which are monitored.However, this investigation is now complete.

• Brand Name: OPSITE POST OP 9.5X8.5CM CTN 20
• 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: 10261830
• MDR Text Key: 199062296
• Report Number: 8043484-2020-01796
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 66000709
• Device Lot Number: 201928
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/11/2020
• Supplement Dates Manufacturer Received: 12/04/2020
• Supplement Dates FDA Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention