MENDTEC *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-30 for MENDTEC * manufactured by Mendtec.

Event Text Entries

[68259] Hospital submits the following pursuant to 21cfr803. It is based on info reviewed by hartford hosp which it may not have had an opportunity to investigate fully or verify prior to the reporting date. This report shall not be construed as an admission by hartford hospital that it or any of its employees or affiliates caused or contributed to the incident described herein. While the pt was positioned in the new allyn stirrups for a lap. Spleen procedure in the or the left stirrups gave way during the procedure. The left leg internally rotated about 45 degrees the pt sustained no injury.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	107761
MDR Report Key	107761
Date Received	1997-06-30
Date of Report	1997-01-02
Date of Event	1996-12-27
Date Facility Aware	1996-12-27
Report Date	1997-01-02
Date Reported to Mfgr	1997-01-02
Date Added to Maude	1997-07-28
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	3
Initial Report to FDA	3
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	MENDTEC
Generic Name	ALLYN STIRRUP
Product Code	EYD
Date Received	1997-06-30
Returned To Mfg	1996-12-30
Model Number	*
Catalog Number	*
Lot Number	*
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	R
Device Age	UNKNOWN
Implant Flag	N
Date Removed	A
Device Sequence No	1
Device Event Key	105918
Manufacturer	MENDTEC
Manufacturer Address	4230 LBJ FREEWAY SUITE 560 DALLAS TX 75244 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1997-06-30