HEANEY CLAMP UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-10-15 for HEANEY CLAMP UNKNOWN manufactured by Unknown.

Event Text Entries

[317] The infundibuolpelvic ligaments were crossed-clamped with a heaney clamp and upon detaching the uterus from the ligaments, which was singlely clamped, there was an excessive bleed. The ligament was quickly clamped and ligated and the uterus was removed. The bleeding could not be controlled and it was determined to do an open laparotomy. The surgeon stated that the heaney clamp did not hold appropriately therefore necessitating the open procedure. The estmated blood loss was 1200ccdevice 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. 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: invalid data. Corrective actions: device discarded. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1549
• MDR Report Key: 1549
• Date Received: 1992-10-15
• Date of Report: 1992-10-09
• Date of Event: 1992-08-18
• Date Facility Aware: 1992-10-06
• Report Date: 1992-10-09
• Date Reported to FDA: 1992-10-09
• Date Added to Maude: 1992-10-27
• 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: HEANEY CLAMP
• Product Code: HGC
• Date Received: 1992-10-15
• Model Number: UNKNOWN
• Catalog Number: UNKNOWN
• Lot Number: UNKNOWN
• ID Number: UNKNOWN
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1479
• Manufacturer: UNKNOWN

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-10-15