MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-05-14 for PELTON CRANE AIR WATER SYRINGE NI manufactured by Pelton & Crane Co.
[190596]
Rptr took care of a pt who had a brain abscess due to s. Viridans. About 6 weeks before the brain abscess manifested itself, pt had been to dentist for a cleaning. When rptr made the diagnosis, they commented to the pt and family that the organism identified was typical mouth flora and that dental cleaning was a known preceding event associated with brain abscess. The pt and family have seen a television report of brain abscess associated with the equipment referenced above. They called the dentist, and, indeed, this is the tool he used to clean pt's teeth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1021883 |
| MDR Report Key | 333049 |
| Date Received | 2001-05-14 |
| Date of Event | 1999-07-01 |
| Date Added to Maude | 2001-05-18 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PELTON CRANE AIR WATER SYRINGE |
| Generic Name | AIR WATER SYRINGE |
| Product Code | EIB |
| Date Received | 2001-05-14 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 322423 |
| Manufacturer | PELTON & CRANE CO |
| Manufacturer Address | FABRIKSTRASSE 31 BENSHEIM GM 64625 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-05-14 |