MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE POST OP 8.5X9.5CM CTN 6; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66030314

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2018

Event Type  malfunction  

Event Description

It was reported that the product is permeable to water.

Manufacturer Narrative

We have now concluded our investigation into this complaint.The batch record was reviewed and it could be confirmed that the products had progressed through a satisfactory release process which involved testing the product against the requirements of the finished product specification.There was also no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.No complaint sample was available for assessment.A review of the test results for waterproofness for opsite post-op products manufactured in the past three years and no failure result was found.The above investigation did not find any product defect or manufacturing process issue and there was no complaint sample available for assessment.Based on the available information, the cause of the complaint is inconclusive so no action can be taken at present.Once a sample is received, we will assess and make further investigation.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.We will continue to monitor for any adverse trends relating to this product range.

• Brand Name: OPSITE POST OP 8.5X9.5CM CTN 6
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull ; UK
• MDR Report Key: 8187514
• MDR Text Key: 131146880
• Report Number: 8043484-2018-00452
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66030314
• Device Lot Number: 201749
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1