MAUDE Adverse Event Report: JOERNS HEALTHCARE EASYCARE BED; ELECTRIC PATIENT BED

Model Number ECSBED

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Laceration(s) (1946)

Event Date 05/06/2017

Event Type  Injury  

Event Description

It was reported to the manufacturer by the end user, per the end user the nurses assistants were transferring the resident onto the bed, when his left leg was cut by the rough edge on the bed.The following injuries allegedly occurred: laceration on the residents left leg that required 11 stitches.The facility reported that the injured party was treated at a hospital/clinic and released.Complaint#(b)(4) was entered into our system.

• Brand Name: EASYCARE BED
• Type of Device: ELECTRIC PATIENT BED
• 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: 6562834
• MDR Text Key: 75010257
• Report Number: 3009402404-2017-00029
• 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: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ECSBED
• Device Catalogue Number: ECSBED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 95 YR
• Patient Weight: 59