MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-01 for CUB PEDIATRIC CRIB- HYD BASE FL19H manufactured by Stryker Medical-kalamazoo.
[143947008]
It was reported that a pediatric patient was in the crib with his parents in the room when he got his thumb entrapped in the canopy option assembly while it was in the raised position. It was reported that a lidocaine nerve block was done for the patient to keep him calm while his thumb was freed from the canopy option assembly. It was reported that it took approximately an hour for the bio-med department to cut away the assembly in order to free the patient's hand.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2019-00560 |
| MDR Report Key | 8569484 |
| Date Received | 2019-05-01 |
| Date of Report | 2019-05-01 |
| Date of Event | 2019-03-30 |
| Date Mfgr Received | 2019-04-03 |
| Device Manufacturer Date | 2015-04-09 |
| Date Added to Maude | 2019-05-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BRIAN THOMPSON |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693292100 |
| Manufacturer G1 | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CUB PEDIATRIC CRIB- HYD BASE |
| Generic Name | BED, PEDIATRIC OPEN HOSPITAL |
| Product Code | FMS |
| Date Received | 2019-05-01 |
| Catalog Number | FL19H |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Address | 3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-01 |