MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE LARGE 1; DRESSING,WOUND,OCCLUSIVE

Model Number 66801069

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Swelling (2091)

Event Date 07/09/2013

Event Type  Injury  

Event Description

It was reported that the patient experienced an allergic reaction in the armpit; skin reddening, blistering and lesions.

Manufacturer Narrative

(b)(4).

• Brand Name: ALLEVYN LIFE LARGE 1
• 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 LTD.; 101 hessle road; hull HU3 2BN; UK HU3 2BN
• Manufacturer Contact: terry mcmahon ; 970 lake carillon dr; st petersburg 33716
• MDR Report Key: 4889858
• MDR Text Key: 6067879
• Report Number: 8043484-2015-00179
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/09/2013

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: Other
• Device Model Number: 66801069
• Device Catalogue Number: 66801069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/09/2013
• 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