MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PROFORE #2 STANDARD; BANDAGE ELASTIC

Model Number 66801262

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 05/26/2015

Event Type  Injury  

Event Description

It was reported that the patient developed a severe allergic reaction after being bandaged over the last 6 weeks.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: PROFORE #2 STANDARD
• Type of Device: BANDAGE ELASTIC
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2BN; UK HU3 2BN
• Manufacturer (Section G): LOHMAN & RAUSCHER GMBH; johann schorch-gasse 4; postfach 222; vienna ; AU
• Manufacturer Contact: terry mcmahon ; 970 lake carillon drive; saint petersburg, FL 33716
• MDR Report Key: 4931165
• MDR Text Key: 6013423
• Report Number: 8043484-2015-00224
• Device Sequence Number: 1
• Product Code: FQM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 66801262
• Device Catalogue Number: 66801262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability