MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. HYDROSITE AD GENTLE 7.5X7.5CM CTN 10; DRESSING,WOUND,OCCLUSIVE

Catalog Number 66800538

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2020

Event Type  malfunction  

Event Description

It was reported that when the dressing was removed from the wound, there was a residue of silicone adhesive left on the wound and skin around it, so it took extra effort to remove the residue using skin adhesive remover.Although skin-prep was used on the skin around the wound before the dressing was put on in some cases, the same issues occurred.About 50% of the products were affected.There was no patient harm and there is no information about delay.It is impossible to confirm the lot number.

• Brand Name: HYDROSITE AD GENTLE 7.5X7.5CM CTN 10
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• 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: 9718602
• MDR Text Key: 181662287
• Report Number: 8043484-2020-00105
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063835
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800538
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2021
• 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