PROFORE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-09-02 for PROFORE manufactured by Smith & Nephew Medical Ltd..

Event Text Entries

[53781298] .
Patient Sequence No: 1, Text Type: N, H10

[53781299] It was reported that a patient had a very severe allergic reaction following the application of profore.
Patient Sequence No: 1, Text Type: D, B5

[68389694]
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 8043484-2016-00102
• MDR Report Key: 5924081
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2016-09-02
• Date of Report: 2016-07-25
• Date Mfgr Received: 2016-07-25
• Date Added to Maude: 2016-09-02
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MRS CLAUDIA ODOY
• Manufacturer Street: SCHACHENALLEE 29
• Manufacturer City: AARAU 5001
• Manufacturer Country: SZ
• Manufacturer Postal: 5001
• Manufacturer Phone: 0628320660
• Manufacturer G1: STERIPACK MEDICAL OLAND SP. Z O. O.
• Manufacturer Street: LEG, UL. JAPONSKA 1
• Manufacturer City: JELCZ-LASKOWICE 55 220
• Manufacturer Country: PL
• Manufacturer Postal Code: 55 220
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PROFORE
• Generic Name: BANDAGE, ELASTIC
• Product Code: FQM
• Date Received: 2016-09-02
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SMITH & NEPHEW MEDICAL LTD.
• Manufacturer Address: 101 HESSLE ROAD HULL HU3 2BN UK HU3 2BN

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2016-09-02