MAUDE Adverse Event Report: INVAMEX INVACARE I-CLASS HEAVY DUTY TRANSFER BENCH; AID, TRANSFER

Model Number 9670U

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Fall (1848)

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is being reported in an abundance of caution, due to the allegation that the patient was hospitalized following a fall incident involving the transfer bench.Within the medwatch report, "serious injury" was selected as the event report type, and "hospitalization" was selected as the "event outcome." however, the event description itself did not mention details of any injury or medical treatment.Attempts were made to obtain further information about the event, including details of how the back became detached from the bench, the injury that the patient sustained, and why the patient required hospitalization.It was also requested that the transfer bench be returned to invacare for evaluation.However, despite multiple attempts, the complaint reporter did not respond.At this time, the underlying cause of the alleged event is undetermined.It is unknown if the back broke off the transfer bench or if it was not fully engaged into the mounting holes on the seat prior to use, causing it to detach.The details/severity of the patient's injuries and the reason for their hospitalization are also unknown.If additional information becomes available, a supplemental record will be filed.

Event Description

Invacare received a medwatch report from the fda, in which a facility administrator alleged that a resident was sitting on a 9670u transfer bench when the back fell off under pressure, causing the resident to fall backwards.

• Brand Name: INVACARE I-CLASS HEAVY DUTY TRANSFER BENCH
• Type of Device: AID, TRANSFER
• Manufacturer (Section D): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 8896332
• MDR Text Key: 155335449
• Report Number: 9616091-2019-00012
• Device Sequence Number: 1
• Product Code: IKX
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 9670U
• Device Catalogue Number: 9670U
• Device Lot Number: M 20105
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization