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 PROVO NOVIL P SOFT FAST 65210096 manufactured by Heraeus Kulzer Srl.
[74167908]
(b)(4). Narrative for method, results and conclusions codes the device has not been returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[74167909]
(b)(6) male patient had itching and burning sensation in mouth after use of provo novil. Has history of allergic reactions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011203516-2017-00001 |
| MDR Report Key | 6536625 |
| 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 |
| Device Manufacturer Date | 2016-10-20 |
| 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 | PROVO NOVIL P SOFT FAST |
| Generic Name | MATERIAL, IMPRESSION |
| Product Code | ELW |
| Date Received | 2017-05-02 |
| Catalog Number | 65210096 |
| Lot Number | R010039 |
| Device Expiration Date | 2019-10-20 |
| Operator | DENTIST |
| Device Availability | * |
| 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 | 2017-05-02 |