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

Catalog Number MDS86960KDMB

Device Problems Component Falling (1105); Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/31/2014

Event Type  Injury  

Event Description

When using the transfer bench, the end user fell and suffered a right leg fracture.

Manufacturer Narrative

While sitting on the bench and transferring into the tub, it was reported that one of the suction cups ripped and the end user fell onto a tile floor.He suffered a right leg fracture which was immobilised with a brace.He was admitted to the hospital for observation and subsequently discharged with physical therapy and a diagnosis of acute gait dysfunction.The sample was returned and evaluated.All four legs were intact and no leg deformities were noted.One of the two suction cups was found to be ripped.The cause of the tear to the suction cup was not determined.We cannot rule out the possibility the tear was caused by the device being lifted or moved while the suction was engaged and without first releasing the suction to the tub floor.No manufacturing defect was identified during the sample evaluation.It is not clear how the torn suction cup could have caused the end user to fall as the legs were intact, the device was stable and at the same time was able to support the weight of an end user.However, due to the reported injury and in an abundance of caution, this medwatch is being filed.

• Brand Name: TRANSFER BENCH
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 4107099
• MDR Text Key: 4835818
• Report Number: 1417592-2014-00080
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/27/2014

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86960KDMB
• Device Lot Number: N130162158
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/01/2014
• Initial Date FDA Received: 09/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 77