ALLEN S.A.M. STIRRUP/TABLE CLAMP L50000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-02-18 for ALLEN S.A.M. STIRRUP/TABLE CLAMP L50000 manufactured by Allen Medical Systems.

Event Text Entries

[153070] The allen stirrups fell during a vaginal procedure causing the pts leg to fall. "ankle was twisted" upon inspecting allen stirrups noted that the portion that goes into the holder was worn smooth causing the stirrups to be unstable. Holders were supplied by mfr of the allen stirrups.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1018218
• MDR Report Key: 264508
• Date Received: 2000-02-18
• Date of Report: 2000-02-15
• Date of Event: 2000-02-14
• Date Added to Maude: 2000-02-25
• Event Key: 0
• Report Source Code: Voluntary 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: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: ALLEN S.A.M. STIRRUP/TABLE CLAMP
• Generic Name: *
• Product Code: EYD
• Date Received: 2000-02-18
• Model Number: ALLEN S.A.M. STIRRUP
• Catalog Number: L50000
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 256071
• Manufacturer: ALLEN MEDICAL SYSTEMS
• Manufacturer Address: 15627 NEW PKWY. GARFIELD HEIGHTS OH 44128 US

Device Sequence Number: 2

• Brand Name: TABLE CLAMP
• Generic Name: TABLE CLAMP
• Product Code: BWN
• Date Received: 2000-02-18
• Model Number: 40017
• Catalog Number: *
• Lot Number: *
• ID Number: 5108213
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 256074
• Manufacturer: ALLEN MEDICAL SYSTEMS
• Manufacturer Address: 15627 NEW PKWY. GARFIELD HEIGHTS OH 44128 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2000-02-18