ANKLE-FOOT-CALF PLASTICOAT, SMALL RIGHT.

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-04-27 for ANKLE-FOOT-CALF PLASTICOAT, SMALL RIGHT. manufactured by Maramed Precision Corporation.

Event Text Entries

[22073432] Resident fractured tibia & fibula, bone displaced, closed reduction. Unstable fracture. Plasticoat applied by physician over felt and stockinette applied to leg. Nurses assessed condition of distal leg routinely. One month later, drainage observed. When plasticast and dressings removed, five areas of necrotce tissue (front of leg, ankle & top/bottom of foot). Treatment of decabitus continues now since 12/11/93. We believe some of skin breakdown is due to the pressure of device in that it dosen't completely mold to shape leg & ankle. Invalid data - regarding single use labeling of device. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: design, telemetry failure, unanticipated long term complication of procedure, other. Conclusion: device failure related to patient condition, device failure indirectly caused event, device failure indirectly contributed to event, device was out of spec in a manner that relates to event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6548
• MDR Report Key: 6548
• Date Received: 1993-04-27
• Date of Report: 1993-03-17
• Date of Event: 1992-11-13
• Date Facility Aware: 1992-12-11
• Report Date: 1993-03-17
• Date Reported to FDA: 1993-03-17
• Date Added to Maude: 1993-09-27
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ANKLE-FOOT-CALF PLASTICOAT, SMALL RIGHT.
• Product Code: LGF
• Date Received: 1993-04-27
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 6235
• Manufacturer: MARAMED PRECISION CORPORATION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-04-27