MAUDE Adverse Event Report: CAREMED ULTRACARE; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number CAREMED 48X84 ULTRACARE APL MATTRESS , APL CONTROL UNIT

Device Problems Sparking (2595); Connection Problem (2900)

Patient Problem Superficial (First Degree) Burn (2685)

Event Type  Injury  

Event Description

According to (b)(6), the patient might have been getting up from the bed and accidentally pulled the wire.When (b)(6) was fixing the bed, a spark flew up from the pump and burned the finger of the glove she was wearing.There were no injuries and no medical attention needed, but she did wash her finger under cold water.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ULTRACARE
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): CAREMED
• MDR Report Key: 17527614
• MDR Text Key: 321144307
• Report Number: MW5134546
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: CAREMED 48X84 ULTRACARE APL MATTRESS , APL CONTROL UNIT
• Patient Sequence Number: 1