NA - DEVICE #1 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-11-13 for NA - DEVICE #1 * manufactured by Device #1.

Event Text Entries

[15369812] Pressure relief valve positioned on abdomen. Following hysteroscopy, fluid deficit 2300. (i-5600, o=3300) uterine perforation; pt hospitalized overnight for diuresis.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 249775
• MDR Report Key: 249775
• Date Received: 1999-11-13
• Date of Report: 1999-11-10
• Date of Event: 1999-11-09
• Date Facility Aware: 1999-11-09
• Report Date: 1999-11-10
• Date Reported to FDA: 1999-11-10
• Date Added to Maude: 1999-11-17
• 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: NA - DEVICE #1
• Generic Name: POLYP FORCEP
• Product Code: HCZ
• Date Received: 1999-11-13
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 241984
• Manufacturer: DEVICE #1
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	1999-11-13