MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-27 for MASK SURGICAL FOG FREE FOAM AT74535 manufactured by Quiroproductos De Cuauhtemoc S. De R.l. De C.v..
| Report Number | 1423537-2020-00398 |
| MDR Report Key | 9632161 |
| Date Received | 2020-01-27 |
| Date of Report | 2020-01-27 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2020-01-02 |
| Date Added to Maude | 2020-01-27 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PATRICIA TUCKER |
| Manufacturer Street | 3651 BIRCHWOOD DRIVE |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478874151 |
| Manufacturer G1 | QUIROPRODUCTOS DE CUAUHTEMOC S. DE R.L. DE C.V. |
| Manufacturer Street | AVE. RIO STA. CLARA - LOTES 12 |
| Manufacturer City | CUAUHTEMOC, CHIHUAHUA 31543 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 31543 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MASK SURGICAL FOG FREE FOAM |
| Generic Name | MASK, SURGICAL |
| Product Code | FXX |
| Date Received | 2020-01-27 |
| Model Number | AT74535 |
| Catalog Number | AT74535 |
| Lot Number | 19FLH293 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUIROPRODUCTOS DE CUAUHTEMOC S. DE R.L. DE C.V. |
| Manufacturer Address | AVE. RIO STA. CLARA - LOTES 12 CUAUHTEMOC, CHIHUAHUA 31543 MX 31543 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-27 |