MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE N-BRDR 10.5X10.5; DRESSING,WOUND,OCCLUSIVE

Catalog Number 66801748

Device Problems Moisture Damage (1405); Appropriate Term/Code Not Available (3191)

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

Event Date 08/15/2017

Event Type  malfunction  

Event Description

It was reported during a demo fluid test for the product.The product absorbed the fluid over two minutes.The product was checked after 15 minutes and the pad was soaking wet and the fluid could be squeezed out easily.

Manufacturer Narrative

The associated complaint device was not returned for evaluation.(b)(4).

• Brand Name: ALLEVYN LIFE N-BRDR 10.5X10.5
• 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 CV31 3HL; UK CV31 3HL
• Manufacturer Contact: markus poettker ; scachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 6819750
• MDR Text Key: 83839572
• Report Number: 8043484-2017-00222
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 66801748
• Device Lot Number: 1648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/15/2017
• 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