MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE LARGE 1; ALLEVYN LIFE L 15.4X15.4 CTN10

Catalog Number 66801069

Device Problems Device Emits Odor (1425); Device Operates Differently Than Expected (2913)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 12/10/2014

Event Type  malfunction  

Event Description

It was reported, while using allevyn life, the product did not absorb the wound drainage, which resulted in pooling under the dressing and the wound becoming odorous.

• Brand Name: ALLEVYN LIFE LARGE 1
• Type of Device: ALLEVYN LIFE L 15.4X15.4 CTN10
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle rd; hull HU3 2BN; UK HU3 2BN
• Manufacturer Contact: claudia odoy ; schachenallee 29; aarau 5000 ; SZ 5000
• MDR Report Key: 4755188
• MDR Text Key: 5886837
• Report Number: 8043484-2015-00014
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66801069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2015
• 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