MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-10-27 for MILTEX UNK manufactured by Miltex Instrument Co..
[73231]
Pt swallowed mirror/housing when it broke away from spot weld at stem. Both pt and dentist were unaware that the mirror was swallowed until x-rays were taken. Pt passed the mirror/housing on the following.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2431021-1997-00012 |
| MDR Report Key | 129273 |
| Report Source | 05 |
| Date Received | 1997-10-27 |
| Date of Report | 1997-10-16 |
| Date of Event | 1997-01-31 |
| Date Mfgr Received | 1997-10-16 |
| Date Added to Maude | 1997-11-04 |
| 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 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MILTEX |
| Generic Name | #5-MOUTH MIRROR, FRONT SURFACE |
| Product Code | EAX |
| Date Received | 1997-10-27 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| 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 | 126449 |
| Manufacturer | MILTEX INSTRUMENT CO. |
| Manufacturer Address | 6 OHIO DR.-CB6006 LAKE SUCCESS NY 110420006 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-10-27 |