MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD ALLEVYN ADHESIVE 7.5X7.5CM CTN 10; DRESSING,WOUND,OCCLUSIVE

Model Number 66000043

Device Problems Patient-Device Incompatibility (2682); Material Integrity Problem (2978)

Patient Problems Reaction (2414); Tissue Breakdown (2681)

Event Date 06/03/2013

Event Type  Injury  

Event Description

Breakdown and blistering of surrounding skin.Second time of use, some months apart-same reaction.

Manufacturer Narrative

• Brand Name: ALLEVYN ADHESIVE 7.5X7.5CM CTN 10
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD; 101 hessle road; hull HU3 2BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL SUZHOU LTD; cfz a, no. 200 mid suhong rd; suzhou industrial park; suzhou , p.r. C215 021; CH C215021
• Manufacturer Contact: terry mcmahon ; 970 lake carillon dr; st petersburg, FL 33716
• MDR Report Key: 4889825
• MDR Text Key: 6534557
• Report Number: 8043484-2015-00172
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/03/2013

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: Lay User/Patient
• Device Model Number: 66000043
• Device Catalogue Number: 66000043
• Device Lot Number: 50349080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2013
• Initial Date FDA Received: 07/03/2015
• 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): Required Intervention