MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-06-27 for FLEXITIME EASY PUTTY 50034802 manufactured by Heraeus Kulzer Srl.
[78997291]
As allowed by exemption # (b)(4), (b)(4) is submitting the report on behalf of heraeus 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 device has not been returned for evaluation. Reviewed dfu, these instructions are printed in bold type and outlined: if there are substantial undercuts or highly divergent teeth in the impression area, appropriate blocking out must be performed if using flexitime heavy tray or easy putty.
Patient Sequence No: 1, Text Type: N, H10
[78997292]
An (b)(6) female patient with deep undercuts and mobile molars had a flexitime easy putty impression stuck on her mandibular teeth for an hour. The tray and material had to be cut away with a drill and scalpel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011203516-2017-00004 |
| MDR Report Key | 6671223 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-06-27 |
| Date of Report | 2017-06-20 |
| Date of Event | 2017-06-20 |
| Date Facility Aware | 2017-06-20 |
| Date Mfgr Received | 2017-06-20 |
| Date Added to Maude | 2017-06-27 |
| 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 | FLEXITIME EASY PUTTY |
| Generic Name | MATERIAL, IMPRESSION |
| Product Code | ELW |
| Date Received | 2017-06-27 |
| Catalog Number | 50034802 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2017-06-27 |