HEANEY HYSTERECTOMY FORCEPS STRAIGHT * 30-5800

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-09-10 for HEANEY HYSTERECTOMY FORCEPS STRAIGHT * 30-5800 manufactured by Codman, Johnson & Johnson.

Event Text Entries

[137448] Straight honey clamp broke during surgery. Broken piece retrieved from pt's pelvis. No outcome to pt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 239540
• MDR Report Key: 239540
• Date Received: 1999-09-10
• Date of Report: 1999-07-29
• Date of Event: 1999-07-26
• Date Facility Aware: 1999-07-26
• Report Date: 1999-07-29
• Date Reported to FDA: 1999-08-04
• Date Added to Maude: 1999-09-14
• 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
• Reporter Occupation: RISK MANAGER
• 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: HEANEY HYSTERECTOMY FORCEPS STRAIGHT
• Generic Name: HYSTERECTOMY CLAMP, SINGLE TOOTH
• Product Code: HCZ
• Date Received: 1999-09-10
• Model Number: *
• Catalog Number: 30-5800
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 232110
• Manufacturer: CODMAN, JOHNSON & JOHNSON
• Manufacturer Address: 325 PARAMOUNT DR. RAYNHAM MA 02767 US
• Baseline Brand Name: HEANEY-REZAK HYSTERECTOMY FORCEPS
• Baseline Generic Name: FORCEPS, SURGICAL, GYNECOLOGICAL
• Baseline Model No: NA
• Baseline Catalog No: 30-5800
• Baseline ID: NA
• Baseline Device Family: HEANEY-REZAK HYSTERECTOMY FORCEPS
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: Y

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-09-10