MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-03-16 for IMPACTION BUR GUARD * 2296301000 manufactured by Stryker Instruments Kalamazoo.
[21699564]
Pt received a burn on the upper lip facial area during surgery. Prescriptions for pain, antibiotics, and antiviral were administered.
Patient Sequence No: 1, Text Type: D, B5
[21866175]
Device was not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1811755-2007-00013 |
| MDR Report Key | 829837 |
| Report Source | 05 |
| Date Received | 2007-03-16 |
| Date of Report | 2007-03-07 |
| Date of Event | 2007-03-06 |
| Date Mfgr Received | 2007-03-07 |
| Date Added to Maude | 2007-03-23 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JENNIFER HOFFMAN |
| Manufacturer Street | 4100 EAST MILHAM AVE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS |
| Manufacturer Street | 4100 EAST MILHAM AVE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPACTION BUR GUARD |
| Generic Name | GUARD, DISK |
| Product Code | EEJ |
| Date Received | 2007-03-16 |
| Model Number | * |
| Catalog Number | 2296301000 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 817221 |
| Manufacturer | STRYKER INSTRUMENTS KALAMAZOO |
| Manufacturer Address | * KALAMAZOO MI 49001 US |
| Baseline Brand Name | IMPACTION BUR GUARD |
| Baseline Generic Name | GUARD, DISK |
| Baseline Model No | 2296301000 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-03-16 |