BENDY BUMPER 92065 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-10-22 for BENDY BUMPER 92065 * manufactured by Children's Medical Ventures, Inc..

Event Text Entries

[184679] Lead rod (which is covered by plastic and encased in a number of inches thick foam which is then covered by plastic and also flannel covering on outside) broke over course of three months (3 different ones).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1017399
• MDR Report Key: 246009
• Date Received: 1999-10-22
• Date of Report: 1999-10-22
• Date of Event: 1999-07-01
• Date Added to Maude: 1999-10-27
• 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
• 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: BENDY BUMPER
• Generic Name: AID IN POSITIONING NEONATE
• Product Code: FRP
• Date Received: 1999-10-22
• Model Number: 92065
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 238333
• Manufacturer: CHILDREN'S MEDICAL VENTURES, INC.
• Manufacturer Address: 541 MAIN ST. STE 220 SO. WEYMOUTH MA 02190 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1999-10-22