MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-16 for OPTIVIEW SMALL KIT 5502 manufactured by Kerr Hawe Sa.
[62680992]
The symptoms were treated with bentelan. To date, the patient is doing fine. The product was not returned and no lot number was provided; therefore, no evaluation was conducted.
Patient Sequence No: 1, Text Type: N, H10
[62680993]
A dentist indicated two (2) patients experienced an allergic reaction resulting in swollen lips, pain, and ulcers approximately two hours after treatment involving optiview small kit. This is the first of two reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8021023-2016-00002 |
| MDR Report Key | 6183616 |
| Date Received | 2016-12-16 |
| Date of Report | 2016-11-16 |
| Date of Event | 2016-01-01 |
| Date Mfgr Received | 2016-11-16 |
| Date Added to Maude | 2016-12-16 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MARK DZENDZEL |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167802 |
| Manufacturer G1 | KERR HAWE S.A |
| Manufacturer Street | VIA STRECCE 4 |
| Manufacturer City | 6934 BIOGGIO, |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OPTIVIEW SMALL KIT |
| Generic Name | LIP AND CHEEK RETRACTOR |
| Product Code | EIG |
| Date Received | 2016-12-16 |
| Catalog Number | 5502 |
| Operator | DENTIST |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KERR HAWE SA |
| Manufacturer Address | VIA STRECCE 4 6934 BIOGGIO, SWITZERLAND SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2016-12-16 |