MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-16 for NK MEDICAL CRIB 17798 manufactured by Novum Medical Products Inc.
[175219873]
Patient sitting in crib when front side rail fell down. Mother was nearby and patient was not harm. Mother immediately put railing back up, but crib handle came off. Once the handle broke off, we were unable to lower the crib railing with the patient still in the crib. Crib has been removed from patient room and new crib ordered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9595670 |
| MDR Report Key | 9595670 |
| Date Received | 2020-01-16 |
| Date of Report | 2020-01-03 |
| Date of Event | 2020-01-02 |
| Report Date | 2020-01-03 |
| Date Reported to FDA | 2020-01-03 |
| Date Reported to Mfgr | 2020-01-16 |
| Date Added to Maude | 2020-01-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | NK MEDICAL CRIB |
| Generic Name | BED, PEDIATRIC OPEN HOSPITAL |
| Product Code | FMS |
| Date Received | 2020-01-16 |
| Model Number | 17798 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVUM MEDICAL PRODUCTS INC |
| Manufacturer Address | 80 CREEKSIDE DRIVE P.O. BOX 627 AMHERST NY 14228 US 14228 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-16 |