MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-08-14 for DENTAL MIRROR RH4700-008 manufactured by Allegiance Heathcare.
[7761005]
Correction: complaint history from 1/94 through 5/97 has one other issue of this type due to damage by the user.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423537-1997-00163 |
| MDR Report Key | 112632 |
| Report Source | 05,06 |
| Date Received | 1997-08-14 |
| Date of Event | 1997-06-24 |
| Date Mfgr Received | 1997-07-24 |
| Device Manufacturer Date | 1993-01-01 |
| Date Added to Maude | 1997-08-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | DENTAL MIRROR |
| Generic Name | DENTAL MIRROR |
| Product Code | EAX |
| Date Received | 1997-08-14 |
| Returned To Mfg | 1997-08-11 |
| Model Number | RH4700-008 |
| Catalog Number | RH4700-008 |
| Lot Number | UNK |
| ID Number | NA |
| Device Availability | R |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 110563 |
| Manufacturer | ALLEGIANCE HEATHCARE |
| Manufacturer Address | 1500 WAUKEGAN ROAD MCGAW PARK IL 60085 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 | 1997-08-14 |