MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-20 for MEDICHOICE PRIMAGARD80 TIE SOFT BILL GREEN PG4-2161 manufactured by Owens & Minor Distribution, Inc..
[139302546]
Soft bill green surgical masks pg4-2161 are causing skin breakouts on two nurses. After minimal amount of time in contact with skin, employee noted burning sensation on cheeks and once mask was removed cheeks (where top edge of mask was touching) was visually reddened and bumpy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8435607 |
| MDR Report Key | 8435607 |
| Date Received | 2019-03-20 |
| Date of Report | 2019-03-13 |
| Date of Event | 2019-02-28 |
| Report Date | 2019-03-13 |
| Date Reported to FDA | 2019-03-13 |
| Date Reported to Mfgr | 2019-03-20 |
| Date Added to Maude | 2019-03-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDICHOICE PRIMAGARD80 TIE SOFT BILL GREEN |
| Generic Name | MASK, SURGICAL |
| Product Code | FXX |
| Date Received | 2019-03-20 |
| Model Number | PG4-2161 |
| Catalog Number | PG4-2161 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OWENS & MINOR DISTRIBUTION, INC. |
| Manufacturer Address | 9120 LOCKWOOD BLVD MECHANICSVILLE VA 23116 US 23116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-20 |