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

Catalog Number UNKN05004800

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 01/01/1901

Event Type  Injury  

Event Description

In the paper "plastic and reconstructive surgery global open 2020- negative pressure wound therapy reduces wound breakdown and implant loss in prepectoral breast reconstruction" the authors of the study reported that a patient suffer an implant revision while using opsite.No further information is available.

Manufacturer Narrative

The device, used in treatment, has not been returned for evaluation.We have not been able to establish a relationship between the device and the reported event.Probable causes could include issues relating to application techniques and or product failure.A review of the associated batch manufacturing records could not be carried out as no batch/lot number was provided.However, we have no reason to suspect that the product did not meet specifications at the time of manufacture.The complaint history review found further instances of the reported event in the past years.A clinical investigation concluded: during the studying it was reported that the patient suffered an implant revision.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images are required.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should additional medical information be provided this complaint will be re-assessed.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.The associated risk files contain details relating to the harm reported.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.

• Brand Name: UNKN OPSITE
• 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: 10769123
• MDR Text Key: 214085988
• Report Number: 8043484-2020-03434
• 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: foreign,literature,other
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN05004800
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 02/24/2021
• Supplement Dates FDA Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention