MAUDE Adverse Event Report: JOERNS HEALTHCARE DERMAFLOAT LOW AIR LOSS SYSTEM; AIR MATTRESS

Model Number DFLAL-3680-M

Device Problem Device Handling Problem (3265)

Patient Problem Fall (1848)

Event Date 04/22/2016

Event Type  Injury  

Event Description

It was reported to the manufacturer by the end user, per the end user she was scooting off the mattress onto the bedside toilet.She lost her balance and fell onto the floor.The patient went to the e.R.On (b)(6) 2016 due to lower back pain.X-rays were taken and were negative.She was given a prescription for pain medication.Complaint #(b)(4) and ra #(b)(4)were entered into our system to have the mattress system returned to joerns for investigation.As of this writing, the mattress system has not been returned.

• Brand Name: DERMAFLOAT LOW AIR LOSS SYSTEM
• Type of Device: AIR MATTRESS
• 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: 5638209
• MDR Text Key: 44665825
• Report Number: 3009402404-2016-00015
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/06/2016

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: Lay User/Patient
• 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
• Initial Date Manufacturer Received: 04/23/2016
• Initial Date FDA Received: 05/06/2016
• 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: 61 YR