MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-06 for CUB PEDIATRIC CRIB REF-FL19 manufactured by Stryker Medical.
[173758804]
Crib canopy in retracted position, toddler placed thumb in the hole that is used to lock the crib top in place when it is drawn down. Crib had to be manually cut to free the patient's thumb from this hole.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9551522 |
| MDR Report Key | 9551522 |
| Date Received | 2020-01-06 |
| Date of Report | 2019-12-17 |
| Date of Event | 2019-12-15 |
| Report Date | 2019-12-17 |
| Date Reported to FDA | 2019-12-17 |
| Date Reported to Mfgr | 2020-01-06 |
| Date Added to Maude | 2020-01-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUB PEDIATRIC CRIB |
| Generic Name | BED, PEDIATRIC OPEN HOSPITAL |
| Product Code | FMS |
| Date Received | 2020-01-06 |
| Model Number | REF-FL19 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER MEDICAL |
| Manufacturer Address | 3800 E. CENTRE AVE. PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-06 |