MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-02-18 for SUSPEND SEAT STROLLER 1003 PVC1003 manufactured by Care Products.
[43559]
Pt was placed in stroller to promote safe ambulation throughout halls of the unit. Pt fell forward in stroller hitting face on floor, resulting in the fracture of the second cervical vertebrae at the odontoid process.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 68723 |
| MDR Report Key | 68723 |
| Date Received | 1997-02-18 |
| Date Facility Aware | 1996-12-28 |
| Report Date | 1997-01-29 |
| Date Reported to FDA | 1997-01-29 |
| Date Reported to Mfgr | 1997-01-29 |
| Date Added to Maude | 1997-02-19 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUSPEND SEAT STROLLER |
| Generic Name | STROLLER |
| Product Code | LBE |
| Date Received | 1997-02-18 |
| Model Number | 1003 |
| Catalog Number | PVC1003 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 1 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 68694 |
| Manufacturer | CARE PRODUCTS |
| Manufacturer Address | 6 1/2 MILE NORTH WARE RD MCALLEN TX 78504 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-02-18 |