MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-03-09 for OPTIVIEW LIP AND CHEEK RETRACTOR 716-0050 manufactured by Kerrhawe Sa.
[2551822]
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 second of four (4) reports.
Patient Sequence No: 1, Text Type: D, B5
[9754792]
The device and accompanying lip cushions were previously soaked in ventisept m plus disinfectant. The doctor suspected that the disinfectant could have been the cause of the allergic reaction as the blisters and swelling were concentrated primarily in the areas where the cushions had contact with the patient's mouth. The doctor advised the patient to seek medical treatment with a physician. To date, the device involved in the alleged incident was not returned and no lot number was provided; therefore, no further investigation can be conducted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8020994-2012-00002 |
| MDR Report Key | 2486064 |
| Report Source | 05 |
| Date Received | 2012-03-09 |
| Date of Report | 2012-02-10 |
| Date Mfgr Received | 2012-02-10 |
| Date Added to Maude | 2012-03-12 |
| 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 | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. ORLANDO TADEO, JR. |
| Manufacturer Street | 1717 WEST COLLINS AVENUE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167419 |
| Manufacturer G1 | KERRHAWE SA |
| Manufacturer Street | VIA STRECCE 4 |
| Manufacturer City | BIOGGIO, CH-6934 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-6934 |
| Single Use | 3 |
| 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 | 2012-03-09 |
| Catalog Number | 716-0050 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2012-03-09 |