MAUDE Adverse Event Report: INVACARE FLORIDA IVC BARIATRIC BED 9153641598; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number BAR600IVC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

The bed provider stated that he and the patient's case worker have been to the patient's house several times, and he alleged that nothing is wrong with the bed.The provider indicated that the patient hit her ankle on the caster lock through no fault of the bed.Should additional information become available, a supplemental record will be filed.

Event Description

The patient reported that the caster lock sticks out from the bed, and when she bent down to pick up a paper clip off of the ground, she cut on her left leg on the lock.The patient stated that an ambulance came out to patch up her wound and then 3 days later she went to the hospital.She alleged that at the hospital, they told her that the cut was too swollen for stitches, so they packed the wound, and she continues to get it repacked each day.

• Brand Name: IVC BARIATRIC BED 9153641598
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): INVACARE FLORIDA; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer (Section G): INVACARE FLORIDA; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 7052038
• MDR Text Key: 92718522
• Report Number: 1031452-2017-00057
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2017

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: BAR600IVC
• Device Catalogue Number: BAR600IVC
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 147