MAUDE Adverse Event Report: UNKNOWN DRIVE MEDICAL; BATH BENCH

Catalog Number DK12202KD-4

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Death (1802)

Event Date 01/21/2013

Event Type  Death  

Manufacturer Narrative

Please note that this submission package was originally submitted on 01/06/2016 using the test site because i was unaware of the production site.It will be repackage and send through the production site on 03/09/2016.

Event Description

Drive medical received a summons through the mail in regards to the complaints of the estate of (b)(6).As stated on the summons, the victim placed the bath bench in the bath rub to sit on while she took a shower.The victim had purchased the product approximately 2 years prior.While the victim was sitting on the bench, one of the rubber pieces on the leg of the bath bench that held the bath bench fell off and into the bath tub drain, clogging the drain.The water level continued to fill higher and the victim fell into the bath tub and drowned.She died the same day from drowning.Due to the lack of product information, we were unable to identify the manufacturer of the product.This report is based solely from the information provided from the summons.

• Brand Name: DRIVE MEDICAL
• Type of Device: BATH BENCH
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 5489644
• MDR Text Key: 39986951
• Report Number: 2438477-2016-00001
• 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: Distributor
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 01/06/2016,12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: DK12202KD-4
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/06/2016
• Distributor Facility Aware Date: 12/07/2015
• Device Age: 5 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): Death