MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE L 15.4X15.4 CTN10; DRESSING, WOUND, OCCLUSIVE

Model Number 66801069

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problem Purulent Discharge (1812)

Event Date 09/09/2015

Event Type  Injury  

Event Description

It was reported that after four days the dressing could not absorb more of the exudate and exudate ran out during the adhesive and damaged the skin.

• Brand Name: ALLEVYN LIFE L 15.4X15.4 CTN10
• 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 LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: terry mcmahon ; 970 lake carillon dr; st petersburg, FL 33716
• MDR Report Key: 5123441
• MDR Text Key: 27375811
• Report Number: 8043484-2015-00273
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 66801069
• Device Catalogue Number: 66801069
• Device Lot Number: 1441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2015
• 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): Required Intervention