MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-02-17 for HEDSTROM FILE 671202 manufactured by Dentsply Tulsa.
[353893]
The doctor reported files are breaking during the procedure. Pt follow-up will be required and reported as the info becomes available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8031010-2004-00078 |
| MDR Report Key | 523785 |
| Report Source | 05 |
| Date Received | 2004-02-17 |
| Date of Report | 2004-01-19 |
| Date Mfgr Received | 2004-01-19 |
| Date Added to Maude | 2004-05-07 |
| 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 | 0 |
| Manufacturer Contact | DR. PATRICIA KIHN |
| Manufacturer Street | 221 W PHILA. STREET SUITE 60 |
| Manufacturer City | YORK PA 17404 |
| Manufacturer Country | US |
| Manufacturer Postal | 17404 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DNETSPLY MAILFER |
| Manufacturer Street | * |
| Manufacturer City | BALLAIGUES CH-1338 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-1338 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEDSTROM FILE |
| Generic Name | DENTAL HAND INSTRUMENT |
| Product Code | EMR |
| Date Received | 2004-02-17 |
| Model Number | NA |
| Catalog Number | 671202 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 512913 |
| Manufacturer | DENTSPLY TULSA |
| Manufacturer Address | 608 ROLLING HILLS DRIVE JOHNSON CITY TN 37604 US |
| Baseline Brand Name | HEDSTROM FILE |
| Baseline Generic Name | DENTAL HAND INSTRUMENT |
| Baseline Catalog No | 671202 |
| Baseline Device Family | HEDSTROM |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-02-17 |