326-1-1 ADULT FRAME LEG EXERCISER 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 1992-07-31 for 326-1-1 ADULT FRAME LEG EXERCISER N/A manufactured by Stryker Surgical.

Event Text Entries

[18165068] At midnight, the start of thursday, may 7, 1992, the stryker surgical adult frame leg exerciser was placed upon the patient's left leg. The patient was observed during nursing rounds at 1:00 a. M. With nothing abnormal noticed. At 2:00 a. M. (during nursing rounds) the patient was found with her foot and ankle between the stable part of the device and the bars and padding which move up and down. The patient was transported to the emergency room and an x-ray of the effected part taken. The incident resulted in a chip fracture of the left metatarsal. Device not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. Date last serviced: 01-feb-92. Service provided by: distributor. Invalid data - service records availability. No imminent hazard to public health claimed. 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: invalid data. Corrective actions: device temporarily removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3435
• MDR Report Key: 3435
• Date Received: 1992-07-31
• Date of Report: 1992-05-21
• Date of Event: 1992-05-07
• Date Facility Aware: 1992-05-07
• Report Date: 1992-05-21
• Date Reported to FDA: 1992-05-21
• Date Reported to Mfgr: 1992-05-21
• Date Added to Maude: 1993-04-20
• 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: 326-1-1 ADULT FRAME LEG EXERCISER
• Generic Name: N/A
• Product Code: HRW
• Date Received: 1992-07-31
• Model Number: 326-1-1
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: N/A
• Operator: OTHER CAREGIVERS
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3195
• Manufacturer: STRYKER SURGICAL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-31