MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-18 for MASK, SURGICAL SOFT-TOUCH SENSITIVE WHT AT73035 manufactured by Quiroproductos De Cuauhtemoc S. De R.l. De C.v..
[120691815]
The involved lot number was not provided, therefore the device history record could not be reviewed. This issue needs to be investigated by sample evaluation; however the sample was not available for investigation, therefore the root cause could not be determined. All manufactured product is made from qualified materials that are inspected prior to release to manufacturing for production. In addition, all manufactured product must meet product specification and manufacturing process requirements before final release. All operators are certified in their respective operations. Documented awareness training was provided to the employees involved in the processing of this product alerting them to this kind of issue. We will continue to monitor complaints regarding such issues.
Patient Sequence No: 1, Text Type: N, H10
[120691816]
Sales rep was notified that (b)(6) was on steroids because of skin irritation issues with the mask. The customer did not provide any additional specifics regarding the crna and the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2018-00238 |
| MDR Report Key | 7887952 |
| Date Received | 2018-09-18 |
| Date of Report | 2018-09-18 |
| Date of Event | 2018-08-23 |
| Date Mfgr Received | 2018-08-23 |
| Date Added to Maude | 2018-09-18 |
| 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, SURGICAL SOFT-TOUCH SENSITIVE WHT |
| Generic Name | MASK, SURGICAL |
| Product Code | FXX |
| Date Received | 2018-09-18 |
| Catalog Number | AT73035 |
| Lot Number | UNKNOWN |
| 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 | 2018-09-18 |