N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-04-09 for N/A manufactured by Smith & Nephew Richards, Inc..

Event Text Entries

[4242] Knee immobilizer was put on patient's leg to prevent flexion after placement of temporary pacemaker. Patient began complaining of numbness and tingling; when device removed, patient had developed a foot drop. Patient received extensive physical therapy but foot drop hasn't responded to therapy thus neuropraxia seems unlikely and peroneal palsy more likelyinvalid data - regarding single use labeling of device. Patient medical status prior to event: critical condition. Invalid data - regarding 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. Invalid data - whether device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 5466
• MDR Report Key: 5466
• Date Received: 1993-04-09
• Date of Report: 1993-03-08
• Date of Event: 1992-08-14
• Date Facility Aware: 1992-11-03
• Report Date: 1993-03-08
• Date Reported to Mfgr: 1992-11-05
• Date Added to Maude: 1993-07-14
• 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

• Generic Name: RICHARDS KNEE IMMOBILIZER
• Product Code: HSP
• Date Received: 1993-04-09
• Model Number: N/A
• Catalog Number: N/A
• Lot Number: UNKNOWN
• ID Number: N/A
• Operator: OTHER
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 5161
• Manufacturer: SMITH & NEPHEW RICHARDS, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-04-09