MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-03-26 for HARTWELL FASTSPLINT FS-802-M manufactured by Hartwell Medical.
[3322187]
(b)(4) responded to a patient with an obvious tib/fib fracture. Hartwell vacuum splint was applied to immobilize the fracture. Upon transfer to the ed bed, crew noticed vacuum splint failed, resulting in patient's leg going out of alignment and a considerable increase in patient's pain level. Manual immobilization was maintained by ems crew and ed staff.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5029541 |
| MDR Report Key | 3029226 |
| Date Received | 2013-03-26 |
| Date of Report | 2013-03-26 |
| Date of Event | 2013-03-12 |
| Date Added to Maude | 2013-04-02 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HARTWELL FASTSPLINT |
| Generic Name | VACUUM SPLINT |
| Product Code | NOC |
| Date Received | 2013-03-26 |
| Returned To Mfg | 2013-03-26 |
| Model Number | FS-802-M |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HARTWELL MEDICAL |
| Manufacturer Address | 6354 CORTE DEL ABETO SUITE F CARLSBAD CA 92011 US 92011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-03-26 |