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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN DRIVE; TRANSFER BENCH
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UNKNOWN DRIVE; TRANSFER BENCH Back to Search Results
Model Number 12005KD-1
Device Problem Insufficient Information (3190)
Patient Problem Laceration(s) (1946)
Event Date 02/08/2017
Event Type  Injury  
Event 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.
 
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Brand Name
DRIVE
Type of Device
TRANSFER BENCH
Manufacturer (Section D)
UNKNOWN
MDR Report Key11766906
MDR Text Key248788327
Report Number2438477-2021-00015
Device Sequence Number1
Product Code IKX
UDI-Device Identifier00822383225555
UDI-Public822383225555
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number12005KD-1
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/03/2021
Distributor Facility Aware Date04/17/2017
Event Location Hospital
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Disability;
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