MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-29 for HEDSTROEM-FILES, CC+ V010073025020 manufactured by Vdw Gmbh.
[36284484]
In this incident there was a report of injury to the pt. However, as a result of this malfunction, the potential for surgical intervention exists (though inadvisable per expert opinion provided by dr. (b)(6), dated (b)(6) 2002) to preclude injury or illness that would necessitate medical or surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events. This event, therefore, is reportable per 21cfr part 803.
Patient Sequence No: 1, Text Type: N, H10
[36284485]
The dentist reported separating a file in the pt's tooth during a dental procedure and elected to fill around the file to complete the procedure. There was no report of injury to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611053-2004-00437 |
| MDR Report Key | 5316084 |
| Date Received | 2004-09-29 |
| Date of Report | 2004-08-30 |
| Date of Event | 2003-09-19 |
| Date Mfgr Received | 2004-08-30 |
| Date Added to Maude | 2015-12-21 |
| 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 | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. PATRICIA KIHN |
| Manufacturer Street | 221 W. PHILA. ST STE 60 SUSQUEHANNA COMMERCE CTR W. |
| Manufacturer City | YORK PA 17404 |
| Manufacturer Country | US |
| Manufacturer Postal | 17404 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | VDW GMBH |
| Manufacturer Street | BAYERWALDSTRASSE 15 |
| Manufacturer City | MUNCHEN 81737 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 81737 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HEDSTROEM-FILES, CC+ |
| Generic Name | DENTAL FILE |
| Product Code | EIY |
| Date Received | 2004-09-29 |
| Model Number | NA |
| Catalog Number | V010073025020 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VDW GMBH |
| Manufacturer Address | MUNCHEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-09-29 |