SKILL CARE W/C BELT UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-09-15 for SKILL CARE W/C BELT UNKNOWN manufactured by Skillcare.

Event Text Entries

[335] Resident put to bed by two cna's who inappropriately chase a wheelchair waist restraint to restrain him in bed. The belt was secured on either side of bed but sat across residents waist rather than around it. The resident easily slipped out from under the restraint climbed over or by passen bedrails and was found in their on right hip which was fixed and required surgical repair. The device failed only in that it was applied incorrectly by the laser. Thought it contributed to incident was not a direct causeinvalid data - regarding single use labeling of device. Patient medical status prior to event: satisfactory 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 not used as labeled/indended. Device was evaluated after the event. Method of evaluation: other. Results of evaluation: misapplication of device. Conclusion: user error contributed to event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device discarded, other. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1330
• MDR Report Key: 1330
• Date Received: 1992-09-15
• Date of Report: 1992-09-03
• Date of Event: 1992-08-01
• Date Facility Aware: 1992-08-01
• Report Date: 1992-09-03
• Date Reported to FDA: 1992-09-03
• Date Added to Maude: 1992-09-22
• 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: SKILL CARE W/C BELT
• Generic Name: UNKNOWN
• Product Code: IQB
• Date Received: 1992-09-15
• Model Number: UNKNOWN
• Catalog Number: UNKNOWN
• Lot Number: UNKNOWN
• ID Number: UNKNOWN
• Operator: OTHER
• Device Availability: Y
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 1274
• Manufacturer: SKILLCARE

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-09-15