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 2018-09-13 for FLEXITME MONOPHASE 66035993 manufactured by Kulzer, Llc.
[120105473]
This occurred in (b)(6). (b)(4). 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. The returned device has been analyzed and tests completely within specifications.
Patient Sequence No: 1, Text Type: N, H10
[120105474]
Female patient, (b)(6) treated with flexitime monophase impression material. She developed swelling and redness of the mucosa afterwards.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011203516-2018-00003 |
| MDR Report Key | 7872196 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-09-13 |
| Date of Report | 2018-08-17 |
| Date of Event | 2018-08-17 |
| Date Facility Aware | 2018-08-17 |
| Date Mfgr Received | 2018-08-17 |
| Device Manufacturer Date | 2016-09-01 |
| Date Added to Maude | 2018-09-13 |
| 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 | MRS. RITA ROGERS |
| Manufacturer Street | 4315 SOUTH LAFAYETTE BLVD. |
| Manufacturer City | SOUTH BEND 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer G1 | KULZER, LLC |
| Manufacturer Street | CLADERIA C3 DIETRICH HONOLD 1 |
| Manufacturer City | SACALAZ-JUDET, 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 | FLEXITME MONOPHASE |
| Generic Name | MATERIAL, IMPRESSION |
| Product Code | ELW |
| Date Received | 2018-09-13 |
| Returned To Mfg | 2018-08-28 |
| Catalog Number | 66035993 |
| Lot Number | R010069 |
| Device Expiration Date | 2019-09-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 12 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KULZER, LLC |
| Manufacturer Address | CLADERIA C3 DIETRICH HONOLD 1 SACALAZ-JUDET, TIMIS 307370 RO 307370 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-13 |