MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; BAR,ASSIST,FLIP DOWN FOR FCE1232 BED

Catalog Number FCE1232ABN

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

Patient Problem Laceration(s) (1946)

Event Date 07/31/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient on fall precautions experienced a backward fall while trying to get out of bed.According to the facility contact, the assist bar did not cause or contribute to the fall that was experienced.The facility contact states that a plastic piece on the assist bar had previously fallen off.When the patient fell, she hit the base of the back of her head on the metal part of the assist bar and experienced a head laceration.The patient was taken to a local hospital.A ct scan was performed with no acute findings reported.The patient reportedly received five (5) internal sutures and three (3) external sutures to close the head laceration.The patient was discharged after evaluation and treatment and is reportedly "recovering and doing okay at this time." no sample was returned to the manufacturer for evaluation.A root cause for the reported incident was unable to be determined.Due to the reported need for medical intervention, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that a patient experienced a backward fall and hit her head on the assist bar.

• Type of Device: BAR,ASSIST,FLIP DOWN FOR FCE1232 BED
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, il ; 9311458
• MDR Report Key: 10456106
• MDR Text Key: 204529945
• Report Number: 1417592-2020-00057
• Device Sequence Number: 1
• Product Code: FNJ
• UDI-Device Identifier: 40884389106427
• UDI-Public: 40884389106427
• 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: Other
• Type of Report: Initial
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: FCE1232ABN
• Device Lot Number: 54119110001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 111