MAUDE Adverse Event Report: CAREMED SUPPLY, INC. ULTRACARE-35X84-M; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number MAT_A 35X87 ULTRACARE NARROW APL

Patient Problem Fall (1848)

Event Date 11/15/2022

Event Type  Injury  

Event Description

(b)(6) called in stating that the facility needed a new mattress for the patient with bolsters because the patient keeps falling out of bed.I asked if the patient had been injured in any of the falls and (b)(6) stated that not so far.The original order was order # (b)(4) and was delivered back on (b)(6) 2022.Assets 14896467/r150348 were delivered at that time.It does not appear that any switch outs or requests for servicing have been received for this equipment since it was delivered.The pick up that was placed on 11/15 (b)(4) now has the "patient fall incident all items must be switched out and quarantined at the warehouse until further instruction." note in it.New order # (b)(4) has been sent out for a mattress with bolsters and a request has been sent to dispatch to see if we can expediate the order for delivery asap.Disclaimer statement: this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ULTRACARE-35X84-M
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): CAREMED SUPPLY, INC.
• MDR Report Key: 17567757
• MDR Text Key: 321546890
• Report Number: MW5144701
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MAT_A 35X87 ULTRACARE NARROW APL
• Device Catalogue Number: ULTRACARE-35X84-M
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/16/2023
• Patient Sequence Number: 1
• Patient Sex: Female