MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-08-14 for V MUELLER DENTAL MIRROR RH4700-008 manufactured by V Mueller.
[16473264]
Pt awake - the dr used the dental mirror to assist in spraying the pt's throat for a bronchoscopy. The mirror broke off the shaft, and the pt swallowed it. X-rays were taken and after discussion with the pt, surgical service did an esophageal gastric dilitation and extracted the mirror from the pt's esophagus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 112628 |
| MDR Report Key | 112628 |
| Date Received | 1997-08-14 |
| Date of Report | 1997-07-14 |
| Date of Event | 1997-06-24 |
| Date Facility Aware | 1997-06-24 |
| Report Date | 1997-07-14 |
| Date Reported to Mfgr | 1997-07-14 |
| Date Added to Maude | 1997-08-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | V MUELLER DENTAL MIRROR |
| Generic Name | DENTAL MIRROR |
| Product Code | EAX |
| Date Received | 1997-08-14 |
| Model Number | RH4700-008 |
| Catalog Number | RH4700-008 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 110563 |
| Manufacturer | V MUELLER |
| Manufacturer Address | 1210 WAUKEGAN BLVD MCGAW PARK IL 600856788 US |
| Baseline Brand Name | DENTAL MIRROR |
| Baseline Generic Name | DENTAL MIRROR |
| Baseline Model No | RH4700-008 |
| Baseline Catalog No | RH4700-008 |
| Baseline ID | NA |
| Baseline Device Family | DENTAL MIRROR |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-08-14 |