MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 1997-03-01 for SIROPRO T1L AIR SCALER 8925729 manufactured by Siemens Medical Systems.
[21608309]
Foreign mfg in the tip of the dental scaler had broken off in a pt's mouth. If this failure was to reoccur, the worst case scenario would be the pt possibly swallowing or inhaling part of the scaler tip. Co has no reports of any injuries due to this type of product malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010024-1997-00073 |
| MDR Report Key | 77844 |
| Report Source | 01,07 |
| Date Received | 1997-03-01 |
| Date Mfgr Received | 1997-02-20 |
| Date Added to Maude | 1997-03-25 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIROPRO T1L AIR SCALER |
| Generic Name | DENTAL AIR SCALER |
| Product Code | EMN |
| Date Received | 1997-03-01 |
| Model Number | T1L |
| Catalog Number | 8925729 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | * |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 77490 |
| Manufacturer | SIEMENS MEDICAL SYSTEMS |
| Manufacturer Address | FABRIKSTRASSE 31 BENSHEIM GERMANY GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-03-01 |