MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE 12.9 X 12.9CM; DRESSING,WOUND,OCCLUSIVE

Model Number 66021068

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Skin Irritation (2076)

Event Date 04/27/2017

Event Type  Injury  

Event Description

It was reported that the allevyn is not wicking away drainage, sitting on top of dressing, causing maceration to peri wound.

• Brand Name: ALLEVYN LIFE 12.9 X 12.9CM
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH&NEPHEW MEDICAL(SUZHOU) LIMITED.; no.12 wuxiang road.; suzhou, jiangsu province 21502 1; CH 215021
• Manufacturer Contact: markus poettker ; schachenallee 29; SZ 5001
• MDR Report Key: 6614640
• MDR Text Key: 76752846
• Report Number: 8043484-2017-00156
• Device Sequence Number: 1
• Product Code: NAD
• 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
• Reporter Occupation: Other
• 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: 66021068
• Device Catalogue Number: 66021068
• Device Lot Number: 201632
• 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
• 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