MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-07-11 for FLEXITIME EASY PUTTY 50034802 manufactured by Kulzer Srl.
[113747085]
(b)(4). Although we have not established that the device cause or contributed to the event, we're reporting out of an abundance of caution and to remain compliant with 21 cfr 803. Additional information surrounding event: reporting staff member stated that she was not in the room with the patient when the reaction occured, but that she is aware of the details due to the patient being the sister of one of the hygienist's at the office. Details are as follows: after impressions were taken with flexitime easy putty and flexitime correct flow the patient felt as if her throat was closing and she was having a hard time breathing. Patient remained at the dental office for an hour and then left, taking her children to lunch. Patient did not seek medical attention. Patient's sister who is an office employee followed up with her the next day and the patient's symptoms had resolved. Lot number of material is not available as the material used for the patient was completely used and the cartridge was disposed of. Office reviewed the sds online and is stating that one of the ingredients listed, has a potential to affect patients who have a shell fish allergy (global safety manager was consulted on this claim via info mail). Flexitime correct flow is submitted to fda as well using reporting number 3011203516-2018-00002.
Patient Sequence No: 1, Text Type: N, H10
[113747086]
Impressions were being taken on patient for invisalign. Patient felt like her throat was closing. Follow up with office: after impressions were taken with ft ep and cf the patient felt as if her throat was closing and she was having a hard time breathing. Patient remained at the dental office for an hour and then left. Patient did not seek medical attention. Patient's sister who is an office employee followed up with her the next day and the patient's symptoms had resolved. Lot number of material is not available as the material used for the patient was completely used and the cartridge was disposed of. Office reviewed the sds online and is stating that one of the ingredients listed, has a potential to affect patients who have a shell fish allergy (global safety manager was consulted and responded, "i screened the ingredients list of the products. I have no clue, which of the ingredients might initiate a cross-allergic reaction with seafood or shellfish and i never heard of such a cross-reaction.. If they are asking if we are aware of such a reaction, i can clearly state no! "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011203516-2018-00001 |
| MDR Report Key | 7678809 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-07-11 |
| Date of Report | 2018-07-09 |
| Date of Event | 2018-06-15 |
| Date Facility Aware | 2018-06-15 |
| Date Mfgr Received | 2018-06-15 |
| Date Added to Maude | 2018-07-11 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS AMBER BROWN |
| Manufacturer Street | 4315 S. LAFAYETTE BLVD |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer Phone | 5472995411 |
| Manufacturer G1 | KULZER, LLC |
| Manufacturer Street | 4315 S. LAFAYETTE BLVD |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXITIME EASY PUTTY |
| Generic Name | IMPRESSION MATERIAL |
| Product Code | ELW |
| Date Received | 2018-07-11 |
| Catalog Number | 50034802 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KULZER SRL |
| Manufacturer Address | DIETCH HONOLD 1 CLADERIA C3 SACALAZ-JUDETUL, TIMIS 307370 RO 307370 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-11 |