* DYND80206

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-12-19 for * DYND80206 manufactured by Medline.

Event Text Entries

[16820096] Bedpan was intact when placed under the patient, was cracked/broken upon removal. Patient sustained small contusion to buttocks.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1041394
• MDR Report Key: 796761
• Date Received: 2006-12-19
• Date of Report: 2006-12-19
• Date of Event: 2006-12-04
• Date Added to Maude: 2006-12-22
• 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: 3
• 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: *
• Generic Name: BEDPAN
• Product Code: FOB
• Date Received: 2006-12-19
• Model Number: DYND80206
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 784314
• Manufacturer: MEDLINE
• Manufacturer Address: * * US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-12-19