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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO. LTD DRIVE; ADAPTOR, HYGIENE
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BLISS HEALTH PRODUCTS CO. LTD DRIVE; ADAPTOR, HYGIENE Back to Search Results
Model Number 12011KD-1
Device Problem Material Integrity Problem (2978)
Patient Problem Skin Infection (4544)
Event Date 12/19/2023
Event Type  Injury  
Event Description
Drive devilbiss healthcare was notified of an incident involving a transfer bench by the end user's spouse, who reported that the front leg of the device collapsed while in use.The end user is an amputee that recently had surgery on his stump.He reportedly fell onto his stump and developed a staphylococcus/pseudomonas infection that was treated with antibiotics.Drive devilbiss healthcare is currently investigating the incident.An update will be filed if additional information becomes available.
 
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Brand Name
DRIVE
Type of Device
ADAPTOR, HYGIENE
Manufacturer (Section D)
BLISS HEALTH PRODUCTS CO. LTD
no.61 &96 zhaoyi road
dongsheng town
zhongshan city, guangdong 52841 4
CH  528414
MDR Report Key18504192
MDR Text Key332791080
Report Number2438477-2024-00002
Device Sequence Number1
Product Code ILS
UDI-Device Identifier00822383224916
UDI-Public00822383224916
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number12011KD-1
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/12/2024
Distributor Facility Aware Date12/29/2023
Event Location Home
Date Report to Manufacturer01/12/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age40 YR
Patient SexMale
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