MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE XL 21X21 CTN10; DRESSING,WOUND,OCCLUSIVE

Model Number 66801070

Device Problems Failure To Adhere Or Bond (1031); Leak/Splash (1354)

Patient Problem Tissue Breakdown (2681)

Event Date 09/17/2014

Event Type  Injury  

Event Description

It was reported that the patient experienced maceration of the wound.The dressing would not adhere resulting in leakage.

• Brand Name: ALLEVYN LIFE XL 21X21 CTN10
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2NB; UK HU3 2NB
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101hessle road; hull HU3 2NB; UK HU3 2NB
• Manufacturer Contact: claudia odoy ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 4887035
• MDR Text Key: 6061346
• Report Number: 8043484-2015-00109
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 66801070
• Device Catalogue Number: 66801070
• Device Lot Number: 1411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2014
• 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): Required Intervention