MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-13 for RESPIRATOR MASK manufactured by 3m.
[80143180]
Patient put on a mask during the day and later on in the evening he got really bad symptoms of a cold. Patient stated that he was sneezing every couple of minutes for 12 hrs, and after that the symptom went away. A week later, patient put the mask on again and he got the same symptoms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070974 |
| MDR Report Key | 6713618 |
| Date Received | 2017-07-13 |
| Date of Report | 2017-07-13 |
| Date of Event | 2017-06-29 |
| Date Added to Maude | 2017-07-14 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | PATIENT |
| 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 | 0 |
| Brand Name | RESPIRATOR MASK |
| Generic Name | RESPIRATOR, SURGICAL |
| Product Code | MSH |
| Date Received | 2017-07-13 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-13 |