MAUDE Adverse Event Report: UNKNOWN INVACARE TRAPEZE BAR WITH TRAPEZE; BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE

Model Number 7740A

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

Patient Problems Pain (1994); Multiple Fractures (4519)

Event Date 07/15/2021

Event Type  Injury  

Manufacturer Narrative

It is unknown if the trapeze was installed onto a floor base or onto the headboard of a bed.It is unclear if only part of the trapeze come loose (such as the grab bar) or if the whole thing detached from the attaching brackets.It is also unknown how the trapeze was being used at the time of the incident and how it came loose, if the hardware was not tightened properly or if there were any broken components.It is unknown if the patient received medical treatment or if he was admitted to the hospital following the incident.Multiple attempts were made to follow-up with the facility to obtain these additional details about the alleged event.At this time, a response has not been received.The underlying cause of the alleged issue is undetermined.Based on the medical device problem code that was selected on the report, the facility indicated that an adverse event (e.G.Patient harm) appears to have occurred, but there does not appear to have been a problem with the device or the way it was used.The date code of the trapeze was not provided, so the manufacturer and manufacturing date could not be determined.If additional information becomes available, a supplemental record will be filed.

Event Description

A report was received from a facility stating a patient alleged that a 7740a trapeze came loose and fell on him, fracturing his clavicle in two places.The report indicates that the patient experienced pain, and they spent an unknown amount of time at a hospital; no medical treatment was reported.

• Brand Name: INVACARE TRAPEZE BAR WITH TRAPEZE
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 12353730
• MDR Text Key: 267701693
• Report Number: 1531186-2021-00002
• Device Sequence Number: 1
• Product Code: LLI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/23/2021,07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 7740A
• Device Catalogue Number: 7740A
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/23/2021
• Distributor Facility Aware Date: 07/26/2021
• Device Age: 1 YR
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 51 YR
• Patient Weight: 78