MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; BENCH,TRANSFER, COMMODE

Catalog Number G98013KD

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

Patient Problem Bone Fracture(s) (1870)

Event Date 12/02/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that the customer, who has been has been paralyzed since 1992, was transferring himself into the shower on (b)(6) 2018, from his wheelchair via a transfer bench, when the customer was pulling his foot over the tub wall his foot slipped which resulted in the customer attempting to catch himself on the back of the transfer bench.When the customer grabbed the transfer bench the pins of the backrest snapped off and the customer fell to the shower floor resulting in the customer landing on his left leg causing a fracture to the extremity.The customer fractured his left leg when he fell in the shower and underwent a tibia/fibula stabilization procedure on (b)(6) 2018 that required screws and plates to be surgically implanted in his left leg.The customer reported that he has had this transfer bench for approximately eight months and continues to use the device.No additional information is available.The device was not returned for evaluation, therefore a device analysis could not be completed and a root cause could not be determined.Due to the reported incident, this medwatch is being filed.No additional information was provided.Should the sample be returned for evaluation or additional relevant information become available a supplemental report will be submitted.

Event Description

It was reported that the end-user experienced a fall from a transfer bench.

• Type of Device: BENCH,TRANSFER, COMMODE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093-2753 ; 8476434960
• MDR Report Key: 8208071
• MDR Text Key: 131892010
• Report Number: 1417592-2018-00138
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: G98013KD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Weight: 79