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 2018-11-21 for COM-FIT SUPER HIGH FILTRATION W/ SHIELD EAR LOOP 20328 manufactured by Dentsply Llc.
[128103333]
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 is available for evaluation, though has not been returned as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
[128103334]
While using a comfit super high filtration w/shield mask, the product causes allergic reactions for the dental "prophylaxe"-assistant, such as itching and red spots. They have worked with this material for years and never had problems. The event outcome is unknown as of this mdr evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2424472-2018-00186 |
| MDR Report Key | 8096441 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-11-21 |
| Date of Report | 2019-01-09 |
| Date Mfgr Received | 2018-12-21 |
| Date Added to Maude | 2018-11-21 |
| 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 | MR. KARL NITTINGER |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494424 |
| Manufacturer G1 | PRESTIGE AMERITECH |
| Manufacturer Street | 7201 IRON HORSE BLVD. |
| Manufacturer City | NORTH RICHLAND HILLS TX 76180 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 76180 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COM-FIT SUPER HIGH FILTRATION W/ SHIELD EAR LOOP |
| Generic Name | MASK, SURGICAL |
| Product Code | FXX |
| Date Received | 2018-11-21 |
| Model Number | NA |
| Catalog Number | 20328 |
| Lot Number | 15171428 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY LLC |
| Manufacturer Address | 1301 SMILE WAY YORK PA 17404 US 17404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-21 |