DEVICE 1 - MILTEX * 30-530

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-07-29 for DEVICE 1 - MILTEX * 30-530 manufactured by Miltex Instrument Co. Inc..

Event Text Entries

[156288] During cervical dilatation and hysteroscopy, uterine perforation suspected. Procedure aborted after serial cervical dilation to approx 7mm and placement of hysteroscope. Intra-operative consult to assist with diagnostic laparoscopy detected a small perforation approximately 1 cm in diameter along the posterior cervix near the lower uterine segment. No bleeding noted; small amount of blood aspirated with copious irrigation. Procedure aborted at this point.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 232865
• MDR Report Key: 232865
• Date Received: 1999-07-29
• Date of Report: 1999-07-21
• Date of Event: 1999-07-14
• Date Facility Aware: 1999-07-16
• Report Date: 1999-07-21
• Date Reported to FDA: 1999-07-21
• Date Reported to Mfgr: 1999-07-21
• Date Added to Maude: 1999-07-27
• 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
• 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: DEVICE 1 - MILTEX
• Generic Name: CERVICAL HEGAR DILATORS
• Product Code: HDQ
• Date Received: 1999-07-29
• Model Number: *
• Catalog Number: 30-530
• Lot Number: *
• ID Number: STAINLESS STEEL-MADE IN GERMAN
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: NO INFO
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 225724
• Manufacturer: MILTEX INSTRUMENT CO. INC.
• Manufacturer Address: 6 OHIO DRIVE CB5006 LAKE SUCCESS NY 110420006 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1999-07-29