MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE S 10.3X10.3 CTN10; DRESSING,WOUND,OCCLUSIVE

Catalog Number 66801067

Device Problem Suction Problem (2170)

Patient Problem Injury (2348)

Event Date 03/09/2018

Event Type  Injury  

Event Description

It was reported that the allevyn life used on a skin tear did not absorb the exudate as expected and left the wound macerated.

Manufacturer Narrative

Our investigation into this complaint has now concluded.As of today, no sample requested for this complaint has become available.Without further information or a sample we cannot progress our investigation or confirm the details supplied in this complaint.A review of the associated batch manufacturing records was not possible due to no lot number being supplied.Due to the nature of the reported issue this has been passed to one of our medical specialists who has made the following comments.¿no clinical supporting documents including photos were provided to confirm the reported issue or conduct a thorough investigation of the reported issue.No further assessment can be rendered.

• Brand Name: ALLEVYN LIFE S 10.3X10.3 CTN10
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 8N; UK HU3 28N
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 8N; UK HU3 28N
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull HU3 2-BN ; UK HU3 2BN
• MDR Report Key: 7392848
• MDR Text Key: 104191236
• Report Number: 8043484-2018-00076
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66801067
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2018
• Initial Date FDA Received: 04/03/2018
• Supplement Dates Manufacturer Received: 03/09/2018; 03/09/2018
• Supplement Dates FDA Received: 04/05/2018; 05/10/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Weight: 61