MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-04-19 for BIOFORM IPN PLASTIC TEETH (20? POSTERIORS) 16686 manufactured by Dentsply Prosthetics.
[105960710]
The patient has declined to return the sample for investigation at this time. While it is unknown if the device used in this case caused or contributed to the patient's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Patient Sequence No: 1, Text Type: N, H10
[105960731]
It was reported that a patient experienced an allergic reaction with symptoms including swelling of the tongue one hour after insertion of a removable lower partial denture fabricated with bioform ipn teeth and valplast resin (competitive product). The patient was treated for symptoms in the er and symptoms alleviated once the device was removed from the mouth for 24 hours.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2585114-2018-00001 |
| MDR Report Key | 7444222 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-04-19 |
| Date of Report | 2018-04-19 |
| Date of Event | 2018-03-19 |
| Date Mfgr Received | 2018-03-23 |
| Date Added to Maude | 2018-04-19 |
| 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. HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494229 |
| Manufacturer G1 | DENTSPLY PROSTHETICS |
| Manufacturer Street | 570 WEST COLLEGE AVENUE |
| Manufacturer City | YORK PA 17404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOFORM IPN PLASTIC TEETH (20? POSTERIORS) |
| Generic Name | DENTURE, PLASTIC, TEETH |
| Product Code | ELM |
| Date Received | 2018-04-19 |
| Model Number | NA |
| Catalog Number | 16686 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY PROSTHETICS |
| Manufacturer Address | 570 WEST COLLEGE AVENUE YORK PA 17404 US 17404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-04-19 |