MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-31 for COM-FIT? PLUSH MASKS CFP-3 0020354FG manufactured by Dentsply Llc.
[146790951]
The device was not returned for evaluation. However, the lot number was provided and retained-product testing and/or dhr review have been requested. The results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
[146790952]
While a customer was using a com-fit plush mask cfp-3, they broke out in a itchy rash over their face. The customer had previously experienced an allergic reaction to another brand of face masks, and applied topical creams that they were previously prescribed to help combat the symptoms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2424472-2019-00087 |
| MDR Report Key | 8660916 |
| Date Received | 2019-05-31 |
| Date of Report | 2019-07-11 |
| Date Mfgr Received | 2019-06-25 |
| Date Added to Maude | 2019-05-31 |
| 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 | 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 | 0 |
| Brand Name | COM-FIT? PLUSH MASKS CFP-3 |
| Generic Name | MASK, SURGICAL |
| Product Code | FXX |
| Date Received | 2019-05-31 |
| Model Number | NA |
| Catalog Number | 0020354FG |
| Lot Number | 19060254 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-05-31 |