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 1992-07-10 for N/A manufactured by Amsco.

Event Text Entries

[2237] Patient was positioned in lithotomy with legs in gyneco stirrup and attached to table with "clark socket assembly". Attachment apparently let loose and patient's leg was extended straight out. Her leg was caught by attending m. D. New attachment was applied to or table and surgery continued. Post surgery, patient complained of left thigh pain. Ortho consultation obtained. X-rays negative. Patient was discharged without pain, but to follow-up with orthopedic visitinvalid 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. Invalid data - whether device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, performance tests performed, visual examination. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: invalid data. 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: 3825
• MDR Report Key: 3825
• Date Received: 1992-07-10
• Date of Report: 1992-05-19
• Date of Event: 1992-05-11
• Date Facility Aware: 1992-05-11
• Report Date: 1992-05-19
• Date Reported to Mfgr: 1992-05-19
• Date Added to Maude: 1993-05-06
• 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: GYNECO STIRRUP HOLDER
• Product Code: ITC
• Date Received: 1992-07-10
• Model Number: N/A
• Operator: OTHER
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3567
• Manufacturer: AMSCO

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-10