FDA Adverse Event
Injury
Summary report: N
OOK COCOON
MDR report key: 11771306
·
Received May 4, 2021
Report
- Report Number
- 3009591865-2021-00008
- Event Type
- Injury
- Date Received
- May 4, 2021
- Date of Event
- April 3, 2021
- Report Date
- May 4, 2021
- Manufacturer
- UMANO MEDICAL INC
- Product Code
- FNL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
WHILE ON COMMUNICATION TO GET ADDITIONAL INFORMATION ON SOME OF BED OPERATIONS TO A CUSTOMER, THE MANUFACTURER WAS INFORMED OF A PATIENT FALL INVOLVING A MINOR INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 668569 | OOK COCOON | HOSPITAL BED | FNL | UMANO MEDICAL INC | FL36 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |