MAUDE Adverse Event Report: JOERNS HEALTHCARE DERMAFLOAT LAL CONTROL UNIT; PATIENT CONTROL UNIT FOR AN AIR MATTRESS

Model Number DFLAL-CU

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Fall (1848)

Event Date 07/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to the manufacturer by the end user, per the end user, facility stated that the clamps on the control unit broke and it fell on a facility employees' right foot, causing swelling and pain.(b)(4) were entered into our system to have the control unit returned to joerns for investigation.As of this writing, the control unit has not been returned.

• Brand Name: DERMAFLOAT LAL CONTROL UNIT
• Type of Device: PATIENT CONTROL UNIT FOR AN 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: 8845635
• MDR Text Key: 152781999
• Report Number: 3009402404-2019-00048
• 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: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2019
• 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 Weight: 77