MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN ADHESIVE 12.; BANDAGE, LIQUID

Model Number 66000044

Device Problem Insufficient Information (3190)

Patient Problem Swelling (2091)

Event Date 06/09/2016

Event Type  Injury  

Event Description

It was reported during training on allevyn.The unit manager informed a sales representative that there was a patient who developed blisters around the allevyn application.

• Brand Name: ALLEVYN ADHESIVE 12.
• Type of Device: BANDAGE, LIQUID
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: claudia odoy ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 5722719
• MDR Text Key: 47309518
• Report Number: 8043484-2016-00067
• Device Sequence Number: 1
• Product Code: KMF
• Combination Product (y/n): N
• PMA/PMN Number: K945330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 66000044
• Device Catalogue Number: 66000044
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other