MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-02-18 for IMPACTION BUR GUARD 2296-301-000 NA manufactured by Stryker Instruments.
[21395965]
Bur guard slid up in drill and burned that pt with 3rd degree burns. Burn was treated with an antibiotic cream and referred to plastic surgeon. There will be residual scarring on the right lip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1811755-1997-00016 |
| MDR Report Key | 70726 |
| Report Source | 06 |
| Date Received | 1997-02-18 |
| Date of Event | 1997-01-02 |
| Date Mfgr Received | 1997-01-27 |
| Date Added to Maude | 1997-02-25 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPACTION BUR GUARD |
| Generic Name | BUR GUARD |
| Product Code | EEJ |
| Date Received | 1997-02-18 |
| Model Number | 2296-301-000 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 70633 |
| Manufacturer | STRYKER INSTRUMENTS |
| Manufacturer Address | 4100 E MILHAM AVE KALAMAZOO MI 49001 US |
| Baseline Brand Name | IMPACTION DRILL BUR GUARD |
| Baseline Generic Name | GUARD, DISK |
| Baseline Model No | 2296-301-000 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | IMPACTION GUARD/SHIELDS |
| Baseline Shelf Life Contained | A |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K953071 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-02-18 |