HOSPITAL BED MATTRESS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-08 for HOSPITAL BED MATTRESS manufactured by .

Event Text Entries

[5213068] When my father was admitted to (b)(6) (b)(6) 2014 for short term rehab post hip repair surgery he was placed inappropriately in long term area of facility. Several days after admission he stated he could not get comfortable in the bed. Upon inspection it was obvious the mattress was old, worn out, with holes, tears, punctures, and deep (large butt) depression in center - which was not only very uncomfortable but harmful to his hip. After notifying the weekend charge nurse the mattress was replaced with another, still in plastic wrapping, mattress which went with him when he eventually was transferred per my request to the correct wing of the facility. My concern is that there may be other dangerous mattresses and mattress covers in this facility. The incident might not have been documented so it's possible no one else is aware of what occurred. For the safety and we'll being of other people who must be admitted to life care i feel it's important to make this known to agency that has power to investigate and correct such deficiencies. I do have exact date (below is inaccurate) and names if you require contact me.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5039570
• MDR Report Key: 4330508
• Date Received: 2014-12-08
• Date of Report: 2014-12-08
• Date of Event: 2014-03-22
• Date Added to Maude: 2014-12-16
• 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: PATIENT FAMILY MEMBER OR FRIEND
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HOSPITAL BED MATTRESS
• Generic Name: BED MATTRESS
• Product Code: FNJ
• Date Received: 2014-12-08
• Operator: LAY USER/PATIENT
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2014-12-08