PROCEL *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-10-04 for PROCEL * manufactured by Gore.

Event Text Entries

[169727] Pt had metatarsal fractures and a fiberglass cast with procel waterproof lining placed on the right foot. Pt complained of burning and pain and the cast was removed 2 weeks later by the surgeon, revealing 2nd degree burns on the top and side of the foot requiring immediate burn wound care at hosp. One possible cause of the wound is an allergy to the procel lining since the pt has had previous fiberglass casts with no allergic response.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1020110
• MDR Report Key: 299562
• Date Received: 2000-10-04
• Date of Report: 2000-10-04
• Date of Event: 2000-10-04
• Date Added to Maude: 2000-10-12
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PROCEL
• Generic Name: WATERPROOF CAST LINER
• Product Code: KIA
• Date Received: 2000-10-04
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 289959
• Manufacturer: GORE
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2000-10-04