MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-13 for MEDICHOICE SURGICAL MASK PG4-2121 manufactured by Owens & Minor Distribution, Inc..
[136043576]
Several employees reported rashes on their face after using surgical mask. The masks were in place for 8 hours. Two employees developed rashes after the masks were taken off. The rash that developed was red bumps noted to bilateral cheeks with "burning" to face, then blisters the following day x 2 employees. Both employees were seen in clinic and advised to change mask types.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8335376 |
| MDR Report Key | 8335376 |
| Date Received | 2019-02-13 |
| Date of Report | 2019-01-25 |
| Date of Event | 2018-12-07 |
| Report Date | 2019-01-25 |
| Date Reported to FDA | 2019-01-25 |
| Date Reported to Mfgr | 2019-02-13 |
| Date Added to Maude | 2019-02-13 |
| 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 SURGICAL MASK |
| Generic Name | MASK, SURGICAL |
| Product Code | FXX |
| Date Received | 2019-02-13 |
| Model Number | PG4-2121 |
| Catalog Number | PG4-2121 |
| Device Availability | N |
| 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 | 2019-02-13 |