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

Catalog Number	FCE1232ABN
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/31/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that a patient experienced a backward fall and hit her head on the assist bar.

• Common Device Name: BAR,ASSIST,FLIP DOWN FOR FCE1232 BED
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 10456106
• Report Number: 1417592-2020-00057
• Device Sequence Number: 4060099
• Product Code: FNJ
• UDI-Device Identifier: 40884389106427
• UDI-Public: 40884389106427
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/26/2020

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: FCE1232ABN
• Device Lot Number: 54119110001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Weight: 111