MAUDE Adverse Event Report: JOERNS HEALTHCARE MX DERMAFLOAT LAL MATTRESS; PATIENT AIR MATTRESS

Model Number DFLAL-3680-M

Device Problem Material Separation (1562)

Patient Problem Fall (1848)

Event Date 03/27/2018

Event Type  Injury  

Event Description

It was reported to the manufacturer by the end user, per the end user, "the top cover of the mattress came off with the patient as they were turning the patient.The patient fell off of the bed and hit their face on a trash can." the patient sustained a cut to the left cheek.The facility cleaned and bandaged the cut.Complaint# (b)(4) were entered into our system to have the mattress returned to joerns for investigation.As of this writing, the mattress has not been returned.

• Brand Name: DERMAFLOAT LAL MATTRESS
• Type of Device: PATIENT AIR MATTRESS
• Manufacturer (Section D): JOERNS HEALTHCARE MX; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas 87499 ; MX 87499
• Manufacturer (Section G): JOERNS HEALTHCARE MX; 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: 7403431
• MDR Text Key: 104591514
• Report Number: 3009402404-2018-00016
• 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: Other
• Type of Report: Initial
• Report Date: 04/06/2018

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-3680-M
• Device Catalogue Number: DFLAL-3680-M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/02/2018
• Initial Date FDA Received: 04/06/2018
• 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): Other
• Patient Age: 102 YR
• Patient Weight: 52