MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-12 for PEDICRAFT manufactured by Pedicraft, Inc..
[183109633]
Patient was in the room with her parents. The left side of the crib rail was down where parents were standing next to the patient, and the right side of the crib was up and locked in place. Per parents', patient was holding on to the crib rails on the right side, the crib rail unlocked and dropped to the next level. Patient flipped over the rail and fell on the floor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9823668 |
| MDR Report Key | 9823668 |
| Date Received | 2020-03-12 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-01-19 |
| Report Date | 2020-02-28 |
| Date Reported to FDA | 2020-02-28 |
| Date Reported to Mfgr | 2020-03-12 |
| Date Added to Maude | 2020-03-12 |
| 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 | RISK MANAGER |
| 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 | PEDICRAFT |
| Generic Name | BASSINET, HOSPITAL |
| Product Code | NZG |
| Date Received | 2020-03-12 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PEDICRAFT, INC. |
| Manufacturer Address | 4134 ST. AUGUSTINE RD. P.O. BOX 5969 JACKSONVILLE FL 32247 US 32247 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-12 |