FDA Adverse Event
Malfunction
Summary report: N
HOSPITAL MATTRESS - CLC (12)
MDR report key: 21071621
·
Received January 2, 2025
Report
- Report Number
- MW5164266
- Event Type
- Malfunction
- Date Received
- January 2, 2025
- Report Date
- December 31, 2024
- Manufacturer
- OFF-LOADING TECHNOLOGIES, INC.
- Product Code
- IKY
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
COMPROMISED MATTRESS, POTENTIAL UNDETECTED FLUID INGRESS FROM INPATIENT/ OUTPATIENT MATTRESS PER (B)(6) PATIENT SAFETY ALERT AL24-01; ALERT AND RECALLS ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 949466 | HOSPITAL MATTRESS - CLC (12) | MATTRESS, FLOTATION THERAPY, NON-POWERED | IKY | OFF-LOADING TECHNOLOGIES, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |