MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO., LTD. PROBASICS; DROP ARM COMMODE

Model Number BSDAC

Device Problem Material Integrity Problem (2978)

Patient Problems Fall (1848); Laceration(s) (1946)

Event Type  Injury  

Event Description

The back left leg bent while the patient was using it and the patient fell.Patient has a wound that opened back up and had to return to er.The er doctor told us to keep it wrapped until he goes to the doctor tomorrow (may 5th).There were no stitches required.

• Brand Name: PROBASICS
• Type of Device: DROP ARM COMMODE
• Manufacturer (Section D): BLISS HEALTH PRODUCTS CO., LTD.; no.96, zhaoyi rd.; dongsheng town; zhongshan city guangdong, ; CH
• MDR Report Key: 10104958
• MDR Text Key: 195111953
• Report Number: 3012316249-2020-00020
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: BSDAC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/01/2020
• Distributor Facility Aware Date: 05/01/2020
• Device Age: 7 MO
• Date Report to Manufacturer: 06/01/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 134