MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GB LITE 8CM X 8CM; DRESSING,WOUND,OCCLUSIVE

Model Number 66801435

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Itching Sensation (1943); Reaction (2414); No Code Available (3191)

Event Date 06/26/2014

Event Type  Injury  

Event Description

The patient experienced large blistering and itching after using allevyn.

Manufacturer Narrative

Based on the limited information available to smith & nephew at this time, this event is deemed to be a serious injury pursuant to 21 c.F.R.Part 803.3.

• Brand Name: ALLEVYN GB LITE 8CM X 8CM
• 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: 4890436
• MDR Text Key: 15900533
• Report Number: 8043484-2015-00214
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 06/26/2014

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: 66801435
• Device Catalogue Number: 66801435
• Device Lot Number: 50481373
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/26/2014
• Initial Date FDA Received: 07/06/2015
• 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