MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2012-03-08 for OPTIVIEW LIP AND CHEEK RETRACTOR 716-0050 manufactured by Kerrhawe Sa.
[2555631]
A doctor alleged that four (4) patients experienced an allergic reaction in the form of red blisters in the mouth and swelling of the lips after placement of the optiview lip and cheek retractor. This is the fourth of four (4) reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2012-00011 |
| MDR Report Key | 2484551 |
| Report Source | * |
| Date Received | 2012-03-08 |
| Date of Report | 2012-02-10 |
| Date Facility Aware | 2012-02-10 |
| Report Date | 2012-03-08 |
| Date Reported to FDA | 2012-03-08 |
| Date Reported to Mfgr | 2012-03-08 |
| Date Added to Maude | 2012-03-08 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIVIEW LIP AND CHEEK RETRACTOR |
| Generic Name | RETRACTOR, DENTAL |
| Product Code | EIG |
| Date Received | 2012-03-08 |
| Catalog Number | 716-0050 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KERRHAWE SA |
| Manufacturer Address | VIA STRECCE 4 BIOGGIO, CH-6934 SZ CH-6934 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-03-08 |