FDA Adverse Event
Malfunction
Summary report: N
HARD CRIB
MDR report key: 17529005
·
Received August 12, 2023
Report
- Report Number
- MW5135934
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- August 7, 2017
- Manufacturer
- HARD MFG. CO., INC.
- Product Code
- FMS
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
- Health Professional
- *
Narratives
Description of Event or Problem · 0
ADDITIONAL INFORMATION RECEIVED ON 3/1/2024 FOR REPORT MW5135934 TO UPDATE PROCODE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Description of Event or Problem · 0
STRYKER MEDICAL WAS NOTIFIED OF A POTENTIALLY REPORTABLE COMPLAINT INVOLVING A PRODUCT FOR WHICH STRYKER IS NOT THE ORIGINAL EQUIPMENT MANUFACTURER OF THE REPORTED DEVICE. THE CUSTOMER ALLEGED A HARD CRIB, SERIAL NUMBER (B)(6), HAD MALFUNCTIONING LATCH ASSEMBLY. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2181426 | HARD CRIB | BED, PEDIATRIC OPEN HOSPITAL | FMS | HARD MFG. CO., INC. | |||
| 356738 | HARD CRIB | BED, PEDIATRIC OPEN HOSPITAL | FMS | HARD MFG. CO., INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |