MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-01-23 for SUSPENDED SEAT STROLLER 1003 PVC1003 manufactured by Care Products.
[16270020]
Pt fell forward in stroller hitting face first onto carpeted floor. X-rays taken. Pt diagnosed with fractured odontoid. Pt had surgery on 12/29/96 to put screw on bone. Pt was unable to eat, therefore, ng tube was used. Due to pt pulling and irritating the site of the surgery, pt had a gastrostomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-1997-00004 |
| MDR Report Key | 64925 |
| Date Received | 1997-01-23 |
| Date of Report | 1997-01-23 |
| Date of Event | 1996-12-28 |
| Date Facility Aware | 1997-01-16 |
| Report Date | 1997-01-23 |
| Date Reported to FDA | 1997-01-23 |
| Date Reported to Mfgr | 1997-01-23 |
| Date Added to Maude | 1997-01-29 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | SUSPENDED SEAT STROLLER |
| Generic Name | STROLLER |
| Product Code | LBE |
| Date Received | 1997-01-23 |
| Model Number | 1003 |
| Catalog Number | PVC1003 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 65042 |
| Manufacturer | CARE PRODUCTS |
| Manufacturer Address | 6 1/2 MILE NORTH WARE RD MCALLEN TX 78504 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-01-23 |