MAUDE Adverse Event Report: JOERNS HEALTHCARE DELUXE ASSIST HANDLE; PATIENT ASSIST HANDLE

Model Number F028

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Laceration(s) (1946)

Event Date 10/04/2017

Event Type  Injury  

Event Description

It was reported to the manufacturer by the end user, per the end user, staff was transferring resident back into the bed.On the assist handle, a piece that connects to the side of the bed with a long rectangle u piece of metal was not welded completely over.It was rough and jagged and resulted in a scrape on the residents leg from a jagged piece of metal.The resident sustained a laceration to the lower left leg and was sent to the the er for evaluation/treatment.(b)(4) were entered into our system to have the assist handle returned to joerns for investigation.As of this writing, the assist handle has not been returned.

• Brand Name: DELUXE ASSIST HANDLE
• Type of Device: PATIENT ASSIST HANDLE
• 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: 6981199
• MDR Text Key: 90395079
• Report Number: 3009402404-2017-00053
• Device Sequence Number: 1
• Product Code: FNL
• 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: 10/26/2017

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: Lay User/Patient
• Device Model Number: F028
• Device Catalogue Number: F028
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2017
• Initial Date FDA Received: 10/26/2017
• 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: 88 YR