MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO. LTD DRIVE; ADAPTOR, HYGIENE

Model Number	12011KD-1
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Blister (4537)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a transfer bench by a provider, who reported that the seat started to collapse and caused pressure on the end user's leg, resulting in a blister that required an antibiotic for treatment.Drive devilbiss healthcare is currently investigating the incident.An update will be filed if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: 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 Key: 18748663
• Report Number: 2438477-2024-00007
• Device Sequence Number: 3703510
• Product Code: ILS
• UDI-Device Identifier: 00822383224916
• UDI-Public: 00822383224916
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2024
• Report Date (Section F): 02/21/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 12011KD-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/24/2024
• Event Location: Home
• Date Report to Manufacturer: 02/21/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2024
• 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
• Patient Sex: Male
• Date Report Sent to FDA: 02/21/2024