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

Model Number 12011KD-1

Device Problem Material Integrity Problem (2978)

Patient Problem Blister (4537)

Event Type  Injury  

Event 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
• 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 Key: 18748663
• MDR Text Key: 335882627
• Report Number: 2438477-2024-00007
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 02/21/2024
• Distributor Facility Aware Date: 01/24/2024
• Event Location: Home
• Date Report to Manufacturer: 02/21/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male