MAUDE Adverse Event Report: JOERNS HEALTHCARE COMFORT EXTENSION; BED WIDTH EXTENSION

Model Number COMFEXT

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Laceration(s) (1946)

Event Date 09/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to the manufacturer by the end user, per the end user, during the night, the patient dropped the bed remote.The patient leaned over the side of the bed to get the remote and fell out of the bed.The patient sustained a laceration to the inner left thigh.The patient was transported to the local hospital and went to surgery to repair the laceration with a skin graft.Complaint# (b)(4) and (b)(4) were entered into our system to have the comfext returned to joerns for investigation.As of this writing, the comfext has not been returned.

• Brand Name: COMFORT EXTENSION
• Type of Device: BED WIDTH EXTENSION
• Manufacturer (Section D): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, 87499 ; MX 87499
• Manufacturer (Section G): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, 87499 ; MX 87499
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 9097935
• MDR Text Key: 162866861
• Report Number: 3009402404-2019-00060
• 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: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: COMFEXT
• Device Catalogue Number: COMFEXT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 09/20/2019
• 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: 104