MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE POST-OP VISIBLE 35X10CM CTN 20; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66800141

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

Patient Problem Injury (2348)

Event Date 12/14/2018

Event Type  Injury  

Event Description

It was reported that patient suffered from ¿marks¿ during use of the product.

Manufacturer Narrative

The associated complaint product was not returned for evaluation, please see below the results of our investigation: we have now concluded our investigation.A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.No complaint sample was available for assessment and a review of the complaint history for this defect shows a very low level of complaints for this issue based on volumes manufactured.A clinical assessment concluded that without the requested clinical information, the product sample, surgical report, and labs we are unable to conduct a thorough investigation.Based solely on the provided photos hyper pigmentation is present, we currently unable to rule out if the patient had any underlying comorbidities (not provided) or early post-operative edema as possible contributing factors to the reported adverse skin reaction.Therefore, information provided is insufficient to determine whether the patient¿s symptoms, signs or outcome are due to a preexisting or concurrent medical or surgical condition or procedure, or to an adverse reaction to or experience with the device, one or more of its components, or its intended therapeutic action.A thorough medical assessment cannot be rendered at this time.The future impacted to the patient beyond the adverse skin reaction cannot be concluded.Should additional information become available, the clinical/medical assessment may be re-evaluated.The investigation did not find product defect/manufacturing issue and the complaint sample is unavailable.Based on the information available, the cause of the complaint is inconclusive.However, once a sample is received, we may 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 adverse trends.

• Brand Name: OPSITE POST-OP VISIBLE 35X10CM CTN 20
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 8204892
• MDR Text Key: 131694924
• Report Number: 8043484-2018-00468
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66800141
• Device Lot Number: 201803
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/14/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 12/14/2018
• Supplement Dates FDA Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Weight: 68