UNK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-02-12 for UNK * manufactured by Unk.

Event Text Entries

[20690528] Pt admitted for myomectomy. During procedure physician noted loop had broken and pieces "were missing". Physician used sharp curette and two broken pieces located. During/as a result of attempts to locate pieces, pt sustained perforation of uterus. Procedure cancelled as a result only 75-80% "myona" removed. Pt stable post op. Physician performed 3 procedures that day. This was 2nd procedure. During 3rd procedure loop from same lot broke. No pt injury. The equipment in question is owned and was purchased by hospital. Therefore, the manufacturer and lot number are unknown and unvailable to reporter. The doctor did notify the operating room staff of this incident.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1027555
• MDR Report Key: 443083
• Date Received: 2003-02-12
• Date of Report: 2003-02-11
• Date of Event: 2003-02-10
• Date Added to Maude: 2003-02-20
• Event Key: 0
• Report Source Code: Voluntary 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: UNK
• Generic Name: CURETTE LOOPS
• Product Code: HCY
• Date Received: 2003-02-12
• Model Number: *
• Catalog Number: *
• Lot Number: UNK
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 432059
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-02-12