MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-04-08 for MASK SURGICAL FOGFREE ANTI GLARE AT74635-I manufactured by Quiroproductos De Cuauhtemoc S. De R.l. De C.v..
[141232606]
The customer could not provide the lot number. Without the lot number, the device history record could not be reviewed. The customer discarded the sample. Without the sample, the root cause could not be identified. These devices are made with qualified, tested, and approved materials. The product was made to meet specification requirements, and is not made with natural rubber latex. A review of this product catalog number identified no trends for this issue in the last twelve months. We will continue to monitor complaints for such issues. Awareness documented training was provided to the involved employees, and the quality inspector will continue to monitor the product.
Patient Sequence No: 1, Text Type: N, H10
[141232607]
Nurse states? During the procedure my nose was itching, by the end of the day i had hives around the right side of my mouth. The next day my whole face was swollen?. She saw a physician and was told to keep taking benadryl every 6 hours and was prescribed a prednisone pack for 6 days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2019-00305 |
| MDR Report Key | 8492342 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-08 |
| Date of Report | 2019-04-08 |
| Date of Event | 2019-03-12 |
| Date Mfgr Received | 2019-03-12 |
| Date Added to Maude | 2019-04-08 |
| 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 | 1500 WAUKEGAN RD |
| 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 FOGFREE ANTI GLARE |
| Generic Name | MASK, SURGICAL |
| Product Code | FXX |
| Date Received | 2019-04-08 |
| Catalog Number | AT74635-I |
| Lot Number | NOT AVAILABLE |
| 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 | 2019-04-08 |