MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-21 for MEDICOM SAFEMASK MASTER SERIES 2050 manufactured by Amd Medicom Inc..
[121567672]
Investigation in-progress.
Patient Sequence No: 1, Text Type: N, H10
[121567673]
The fragrance added to the masks caused an allergic reaction. Adverse reactions included, congestion, restricted breathing, watery eyes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611959-2018-00002 |
| MDR Report Key | 7899992 |
| Date Received | 2018-09-21 |
| Date of Report | 2018-09-18 |
| Date of Event | 2018-06-07 |
| Date Mfgr Received | 2018-07-25 |
| Date Added to Maude | 2018-09-21 |
| 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 | MS. DOMINIQUE ABECASSSIS |
| Manufacturer Street | 2555 CHEMIN DE L'AVIATION |
| Manufacturer City | POINTE-CLAIRE (MONTREAL), QUEBEC H9P2Z2 |
| Manufacturer Country | CA |
| Manufacturer Postal | H9P2Z2 |
| Manufacturer G1 | UNITED MEDICAL ENTERPRISES |
| Manufacturer Street | 4049 ALLEN STATION ROAD |
| Manufacturer City | AUGUSTA 30906 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30906 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDICOM SAFEMASK MASTER SERIES |
| Generic Name | MASK |
| Product Code | FXX |
| Date Received | 2018-09-21 |
| Catalog Number | 2050 |
| Lot Number | 1746, 1744, 1447, 1728 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMD MEDICOM INC. |
| Manufacturer Address | 2555 CHEMIN DE L'AVIATION POINTE-CLAIRE (MONTREAL), QUEBEC GA H9P 2Z2 CA H9P 2Z2 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-21 |