MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. *ALLEVYN LIFE 15.4 X 15.4CM; DRESSING,WOUND,OCCLUSIVE

Model Number 66021069

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/17/2017

Event Type  malfunction  

Event Description

It was reported that dressing on a dorsal foot for an edema and blister did not wick away moisture.

Manufacturer Narrative

(b)(4).

• 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; comprehensive free zone; suzhou 21502 1; CH 215021
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 6571556
• MDR Text Key: 75308619
• Report Number: 8043484-2017-00137
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 66021069
• Device Catalogue Number: 66021069
• Device Lot Number: 201628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2017
• 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