MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-05-02 for PROVIL NOVO L 65210096 manufactured by Heraeus Kulzer Srl.
[74168506]
This occurred in (b)(6). As allowed by exemption # (b)(4), (b)(4) (the importer) is submitting the report on behalf of (b)(4) (the manufacturer). Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution. Narrative for section h6 method, results and conclusions codes the device has not been returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[74168507]
A (b)(6) male patient had itching and burning sensation in mouth after use of provo novil. Has history of allergic reactions. Allergy medication was administered, although this product contains no peppermint oil.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011203516-2017-00002 |
| MDR Report Key | 6536618 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-05-02 |
| Date of Report | 2017-04-03 |
| Date of Event | 2017-03-29 |
| Date Mfgr Received | 2017-04-03 |
| Date Added to Maude | 2017-05-02 |
| 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 | MS. RITA ROGERS |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer Phone | 5742995409 |
| Manufacturer G1 | HERAEUS KULZER SRL |
| Manufacturer Street | CLADERIA C3 DIETRCH HONOLD 1 |
| Manufacturer City | SACALAZ-JUDETUL, TIMIS 307370 |
| Manufacturer Country | RO |
| Manufacturer Postal Code | 307370 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROVIL NOVO L |
| Generic Name | MATERIAL, IMPRESSION |
| Product Code | ELW |
| Date Received | 2017-05-02 |
| Catalog Number | 65210096 |
| Lot Number | R010023 |
| Device Expiration Date | 2019-10-20 |
| Operator | DENTIST |
| Device Availability | * |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER SRL |
| Manufacturer Address | CLADERIA C3 DIETRCH HONOLD 1 SACALAZ-JUDETUL, TIMIS 307370 RO 307370 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-05-02 |