MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-17 for MASK, PROCEDURE AT74531 manufactured by Quiroproductos De Cuauhtemoc S. De R.l. De C.v..
[136468907]
The customer was not able to identify the lot number, therefore the device history record could not be reviewed. The actual mask worn was discarded after use. The customer also stated they did not know which box the mask had been pulled from; and due to high usage, the box was probably empty by now, therefore a representative sample also was not available. Since a sample was not provided for evaluation, the root cause could not be identified. It was verified that this device is made with qualified, tested, and approved materials; and the device is made to meet specification requirements. Awareness documented training was provided to the employees involved in the processing of this product in order to make them aware of this issue. All operators are certified in their respective operations. We will continue monitoring customer complaints for issues of this nature.
Patient Sequence No: 1, Text Type: N, H10
[136468908]
Nurse? S face was itchy/red/broke out in rash and hives; and later that night her face became swollen. The next day she went to the urgent care because her face was still swollen and broken out. She received a steroid injection, po steroids, and po antihistamines. These helped, and her face went back to normal within a few days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2019-00271 |
| MDR Report Key | 8346505 |
| Date Received | 2019-02-17 |
| Date of Report | 2019-02-17 |
| Date of Event | 2019-01-21 |
| Date Mfgr Received | 2019-01-21 |
| Date Added to Maude | 2019-02-17 |
| 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 | 0 |
| Brand Name | MASK, PROCEDURE |
| Generic Name | MASK, SURGICAL |
| Product Code | FXX |
| Date Received | 2019-02-17 |
| Catalog Number | AT74531 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-02-17 |