MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 1997-07-23 for NONE UNK manufactured by "a" Company Orthodontics.
[19899662]
Alleged by a statement of claim that a protruding metal component of the headgear stabbed the pt in the eye while he was removing the headgear. The claim states that the pt underwent various treatments in 1988 and ultimately the eye was removed in 1/97.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2018192-1997-90002 |
| MDR Report Key | 108579 |
| Report Source | 01 |
| Date Received | 1997-07-23 |
| Date of Report | 1997-07-23 |
| Date of Event | 1988-11-30 |
| Date Added to Maude | 1997-07-30 |
| 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 | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NONE |
| Generic Name | FACEBOW |
| Product Code | DZB |
| Date Received | 1997-07-23 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 106714 |
| Manufacturer | "A" COMPANY ORTHODONTICS |
| Manufacturer Address | 9900 OLD GROVE RD. SAN DIEGO CA 92131 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 1997-07-23 |