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 2017-10-10 for FLEXITIME MONOPHASE 66035993 manufactured by Kulzer,llc.
[89184469]
As allowed by exemption (b)(4), (b)(4) is submitting the report on behalf of kulzer srl (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. The 510k entry is for flextime, with the first "i" missing. This is the same product, with two diffrent spellings. The device has not been returned for evaluation, but images of the artifact removed from the patient have been examined. The mass appears to consist of flexitime monophase. The dfu, page 20, states: do not swallow and ingest. If health problems arise after swallowing impression material, seek medical attention immediately. Intestinal blockage may arise in rare cases.
Patient Sequence No: 1, Text Type: N, H10
[89184470]
Patient had impression taken on (b)(6) 2017 using flexitime monophase. She swallowed some impression material, which created an intestinal blockage. Five months later, on (b)(6) 2017 she required surgery to remove the blockage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011203516-2017-00005 |
| MDR Report Key | 6937308 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-10-10 |
| Date of Report | 2017-09-14 |
| Date of Event | 2017-09-06 |
| Date Mfgr Received | 2017-09-15 |
| Date Added to Maude | 2017-10-10 |
| 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 | RITA ROGERS |
| Manufacturer Street | 4315 LAFAYETTE BLVD |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer G1 | KULZER,LLC |
| 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 | FLEXITIME MONOPHASE |
| Generic Name | MATERIAL, IMPRESSION |
| Product Code | ELW |
| Date Received | 2017-10-10 |
| Catalog Number | 66035993 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KULZER,LLC |
| Manufacturer Address | CLADERIA C3 DIETRCH HONOLD 1 SACALAZ-JUDETUL, TIMIS 307370 RO 307370 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2017-10-10 |