FDA Adverse Event
Death
Summary report: N
DBQ-BAR,BED ASSIST
MDR report key: 21688067
·
Received March 25, 2025
Report
- Report Number
- 1417592-2025-00141
- Event Type
- Death
- Date Received
- March 25, 2025
- Date of Event
- February 1, 2023
- Report Date
- March 25, 2025
- Manufacturer
- MEDLINE INDUSTRIES LP
- Product Code
- QTC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
IT WAS REPORTED THAT THE USER "BECAME ENTANGLED WITH THE PRODUCT". "THIS LED TO SEVERE LACERATIONS AND BLOOD LOSS. SHE WAS RUSHED TO THE HOSPITAL AND LATER PASSED AWAY". IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem · 0
"ENTANGLED WITH THE PRODUCT. THIS LED TO SEVERE LACERATIONS AND BLOOD LOSS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1696395 | DBQ-BAR,BED ASSIST | QTC | MEDLINE INDUSTRIES LP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 93 YR | Female | Death |