BAROSPERSE ENEMA KIT * 112616 OR 114616

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-31 for BAROSPERSE ENEMA KIT * 112616 OR 114616 manufactured by Lafayette Pharmaceuticals, Inc..

Event Text Entries

[94298] Pt sustained ruptured colon during bg, laceration (3-4cm) occurred approx 10cm into the rectum-anteriorly at the peritoneal reflection.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 146613
• MDR Report Key: 146613
• Date Received: 1997-12-31
• Date of Report: 1997-07-29
• Date of Event: 1997-07-21
• Date Facility Aware: 1997-07-21
• Report Date: 1997-07-30
• Date Reported to Mfgr: 1997-07-30
• Date Added to Maude: 1998-02-03
• 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
• 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: BAROSPERSE ENEMA KIT
• Generic Name: FLEXIBLE ENEMA TIP W/SILICONE INFLATABLE CUFF
• Product Code: FCE
• Date Received: 1997-12-31
• Model Number: *
• Catalog Number: 112616 OR 114616
• 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: 142892
• Manufacturer: LAFAYETTE PHARMACEUTICALS, INC.
• Manufacturer Address: * LAFAYETTE IN 47904 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	1997-12-31