MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. REMOVE WIPES; SOLVENT, ADHESIVE TAPE

Model Number GB403100

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Swelling (2091)

Event Date 05/08/2017

Event Type  Injury  

Event Description

It was reported that upon application, blisters appeared instantly.

• Brand Name: REMOVE WIPES
• Type of Device: SOLVENT, ADHESIVE TAPE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SPAN PACKAGING SERVICES; llc. 4611 dairy road; suite a, greenville; SC 29607
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau ; SZ
• MDR Report Key: 6616339
• MDR Text Key: 76818559
• Report Number: 8043484-2017-00157
• Device Sequence Number: 1
• Product Code: KOX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: GB403100
• Device Catalogue Number: GB403100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1