MAUDE Adverse Event Report: INVACARE HOSPITAL BED

Model Number 02-006

Device Problem Insufficient Information (3190)

Patient Problems Bruise/Contusion (1754); Physical Entrapment (2327)

Event Date 11/03/2014

Event Type  Injury  

Event Description

My son, (b)(6), was asleep in an invacare hospital bed.His leg fell over and his head became entangled in the bed rail.(b)(6) had many bruises and hasn't been the same since.

• Brand Name: HOSPITAL BED
• Type of Device: HOSPITAL BED
• Manufacturer (Section D): INVACARE
• MDR Report Key: 4270562
• MDR Text Key: 5299946
• Report Number: MW5039172
• Device Sequence Number: 1
• Product Code: FNL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 02-006
• Other Device ID Number: 14FF006661
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 28 YR
• Patient Weight: 77