MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-11 for MASK SURG DUCKBILL SENSITIVE WHITE AT51334 manufactured by Quiroproductos De Cuauhtemoc S. De R.l. De C.v..
[135868928]
The lot number was provided, therefore the device history record was able to be reviewed, and no quality issues were reported. The sample was not provided for evaluation, therefore 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. A review of this product catalog number identified no trends being detected for this issue in the last twelve months. Awareness documented training was provided to the employees involved in the processing of this product in order to make them aware of this issue. We will continue monitoring customer complaints for issues of this nature.
Patient Sequence No: 1, Text Type: N, H10
[135868929]
Face broke out in a blister like rash. She put on the mask and within an hour was covered in a rash. She will be seeking medical attention, and has a history of being placed on steroid cream. Customer did not want to provide specifics (age, weight etc).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2019-00268 |
| MDR Report Key | 8328769 |
| Date Received | 2019-02-11 |
| Date of Report | 2019-02-11 |
| Date of Event | 2019-01-14 |
| Date Mfgr Received | 2019-01-15 |
| Device Manufacturer Date | 2018-10-16 |
| Date Added to Maude | 2019-02-11 |
| 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 | 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 SURG DUCKBILL SENSITIVE WHITE |
| Generic Name | MASK, SURGICAL |
| Product Code | FXX |
| Date Received | 2019-02-11 |
| Catalog Number | AT51334 |
| Lot Number | 18KDH335 |
| 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 | 2019-02-11 |