MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-10-18 for OPTIVIEW 716-0050 manufactured by Kerr Hawe S.a.
[163131814]
Patient experienced symptoms of pain, burning discomfort, swollen lips. Patient was recommended to the emergency room and received oral steroid as well as antihistamine. After one week, swelling disappeared. Specific patient information with regards to ethnicity, race and weight was not provided. No lot number was provided therefore manufacture date cannot be determined. The product was not returned and no lot number or part number was provided; therefore, no evaluation can be conducted.
Patient Sequence No: 1, Text Type: N, H10
[163131815]
A complainant alleged that two (2) patients experienced an allergic reaction resulting in swellings, burning and pain in lips. This is the second of two reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8031023-2019-00002 |
| MDR Report Key | 9206083 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-10-18 |
| Date of Report | 2019-10-17 |
| Date Mfgr Received | 2019-09-19 |
| Date Added to Maude | 2019-10-18 |
| 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. PAULO CALLE |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167752 |
| Manufacturer G1 | KERR HAWE S.A |
| Manufacturer Street | VIA STRECCE 4 |
| Manufacturer City | BIOGGIO, 6934 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6934 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIVIEW |
| Generic Name | LIP AND CHEEK RETRACTOR |
| Product Code | EIG |
| Date Received | 2019-10-18 |
| Catalog Number | 716-0050 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KERR HAWE S.A |
| Manufacturer Address | VIA STRECCE 4 BIOGGIO, 6934 SZ 6934 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-10-18 |