MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2018-05-01 for MASK, PROCEDURE, YELLOW AT70021 manufactured by Quiroproductos De Cuauhtemoc S. De R.l. De C.v..
[107035682]
The lot number was provided, therefore the device history record was able to be reviewed, and no quality issues were reported. The customer reported having a sample, but as of this date, no sample has been received from them. Without the sample, we cannot identify the root cause. If a sample is provided at a later date, a follow up report will be filed. This mask is made with qualified, tested, and approved materials. All operators are certified in their respective operations. Awareness training was provided to the involved employees. We will continue to monitor complaints for any such issues.
Patient Sequence No: 1, Text Type: N, H10
[107035683]
Nurse went to put on a mask and was hit with a white powdery substance in her eye. Customer states it is standard policy for employees to seek care/evaluation from employee health services. The nurse was not symptomatic, but as standard protocol, an eyewash was performed. The nurse is a contractor, so the customer did not have any personal information about her.
Patient Sequence No: 1, Text Type: D, B5
[110227018]
The manufacturing facility received the samples on may 14, 2018, and their investigation confirmed the issue. The root cause of the white powdery substance is linting of the mask materials due to the friction of the material during the manufacturing process. We verified that the mask is made with qualified, tested, and approved materials; and that the product was manufactured according to specification. All operators were trained and certified in their respective assembly operations. As stated on the initial medwatch report, the lot number was provided, therefore the device history record was reviewed, and no quality issues were reported. The following actions will be implemented to prevent this event from recurring: awareness documented training was provided to the involved employees to alert them to this issue. A quality alert will be generated to inform employees at similar processes of this issue. A more effective method for cleaning the equipment will be defined in order to reduce the risk of residues occurring from the friction of the material during the manufacturing process. We will continue to monitor complaints for issues of this nature.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423537-2018-00195 |
| MDR Report Key | 7477283 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-05-01 |
| Date of Report | 2018-06-06 |
| Date of Event | 2018-04-04 |
| Date Mfgr Received | 2018-04-04 |
| Device Manufacturer Date | 2018-03-03 |
| Date Added to Maude | 2018-05-01 |
| 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 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, PROCEDURE, YELLOW |
| Generic Name | MASK, SURGICAL |
| Product Code | FXX |
| Date Received | 2018-05-01 |
| Returned To Mfg | 2018-05-14 |
| Catalog Number | AT70021 |
| Lot Number | 18CKH013 |
| Operator | NURSE |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-05-01 |