MAUDE Adverse Event Report: UNKNOWN DRIVE; TRANSFER BENCH

Model Number	12005KD-1
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/08/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a bath safety device.The device has not been returned for evaluation.We are filing this report in an overabundance of caution.A follow-up report will be filed when we receive new information.The end-user was in rehab and was administered mind-altering pain killer medication.He was placed on a bath bench.After he was soaped, they instructed him to slide forward and then attempted to lift him from the chair.At some point while on the chair, his left testicle became caught in an opening in the chair.He was lifted from by his left testicle reportedly causing severe and permanent injury to him, including to his scrotum, testis and male genitalia.

• Brand Name: DRIVE
• Common Device Name: TRANSFER BENCH
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 11766906
• Report Number: 2438477-2021-00015
• Device Sequence Number: 3157768
• Product Code: IKX
• UDI-Device Identifier: 00822383225555
• UDI-Public: 822383225555
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2021
• Report Date (Section F): 05/03/2021

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
• Operator of Device: Health Professional
• Device Model Number: 12005KD-1
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/17/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Date Report Sent to FDA: 05/03/2021