HEANEY-REZEK HYSTERECTOMY FORCEPS 30-5800

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-09-10 for HEANEY-REZEK HYSTERECTOMY FORCEPS 30-5800 manufactured by Johnson & Johnson Professional, Inc..

MAUDE Entry Details

• Report Number: 1219655-1999-00154
• MDR Report Key: 239543
• Report Source: 05,06
• Date Received: 1999-09-10
• Date of Report: 1999-09-10
• Date of Event: 1999-07-26
• Date Mfgr Received: 1999-08-11
• Date Added to Maude: 1999-09-14
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 0
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HEANEY-REZEK HYSTERECTOMY FORCEPS
• Generic Name: FORCEPS, SURGICAL GYNECOLOGICAL
• Product Code: HCZ
• Date Received: 1999-09-10
• Model Number: NA
• Catalog Number: 30-5800
• Lot Number: UNK
• ID Number: NA
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 232110
• Manufacturer: JOHNSON & JOHNSON PROFESSIONAL, INC.
• 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