MAUDE Adverse Event Report: JOERNS HEALTHCARE DERMAFLAOT LAL; PATIENT AIR MATTRESS AND CONTROL UNIT

Model Number DFLAL-CU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 03/14/2017

Event Type  Injury  

Event Description

It was reported to the manufacturer by the end user, per the end user, the room mate was sitting in his wheel chair at the end of the bed with his arm was resting on the control unit and fell asleep.The room mate sustained 2nd degree burn from the control unit to the right mid-fore arm that was cleaned and bandaged by the facility.Complaint#(b)(4) was entered into our system.

• Brand Name: DERMAFLAOT LAL
• Type of Device: PATIENT AIR MATTRESS AND CONTROL UNIT
• Manufacturer (Section D): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas 87499 ; MX 87499
• Manufacturer (Section G): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas 87499 ; MX 87499
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 7063521
• MDR Text Key: 93085282
• Report Number: 3009402404-2017-00056
• 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: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/27/2017

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 Operator: Health Professional
• Device Model Number: DFLAL-CU
• Device Catalogue Number: DFLAL-CU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2017
• Initial Date FDA Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR