FDA Adverse Event
Death
Summary report: N
DBD-BAR,BED ASSIST
MDR report key: 19906900
·
Received August 5, 2024
Report
- Report Number
- 1417592-2024-00783
- Event Type
- Death
- Date Received
- August 5, 2024
- Date of Event
- July 18, 2021
- Report Date
- October 14, 2024
- Manufacturer
- MEDLINE INDUSTRIES LP
- Product Code
- QTC
- Removal / Correction Number
- R-24-120
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION ADDED.
Additional Manufacturer Narrative · 0
IT WAS REPORTED THAT A FALL OCCURRED AND THE CUSTOMER WAS NOT ABLE TO GET OFF THE FLOOR FOR SEVERAL HOURS. ABOUT THREE WEEKS LATER THE CUSTOMER MOVED INTO A "NURSING HOME". IT WAS REPORTED THAT HER HEALTH "CONTINUALLY DECLINED". IT WAS REPORTED THAT "AN EXAM SHOWED THAT THE IMPACT OF THE FALL HAD CAUSED THE MESH INSTALLED TO SUPPORT HER BLADDER TO FAIL. HER BLADDER HAD DESCENDED TO HER COLON. THE ONLY CORRECTION WAS A SURGERY THAT SHE WAS TOO WEAK TO WITHSTAND." DEATH WAS REPORTED ON (B)(6) 2022.
Description of Event or Problem · 0
WEIGHT WAS PLACED ON THE RAIL TO STAND WHEN THE RAIL SLIPPED CAUSED A FALL TO THE FLOOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2264935 | DBD-BAR,BED ASSIST | QTC | MEDLINE INDUSTRIES LP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Female | Death |