MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE POST-OP VISIBLE 10 X8CM CTN 20; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66800136

Device Problem Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/24/2019

Event Type  Injury  

Event Description

It was reported that dr.Has been trialing the post-op opsite visible for the last couple of weeks on his robotic cases.He said the first week his patients came back in follow up and had similar reactions when the dressing was removed.Because of this ¿reaction¿ yellowed discoloration and raised the skin.When the dressings come off, he decided to stop using these dressings.He said the incisions themselves do not look as good when the dressings come off either.Photography evidence available.

• Brand Name: OPSITE POST-OP VISIBLE 10 X8CM CTN 20
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull ; UK
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull HU3 2-BN ; UK HU3 2BN ; 0447940038
• MDR Report Key: 9344162
• MDR Text Key: 167057009
• Report Number: 8043484-2019-00838
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: 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: 66800136
• Device Lot Number: 201901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/19/2019
• Supplement Dates Manufacturer Received: 02/22/2021
• Supplement Dates FDA Received: 02/24/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention