MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-10-24 for MEDICOM SAFEMASK PREMIER ELITE 2046 manufactured by Amd Medicom Inc..
[125916027]
Client reported the following: my hygienist has had a significant respiratory allergic reaction. She was transferred to the hospital urgently. She is fine but we were very scared. We try to find out what could have provoked this reaction. She told me that the sore throat began after she breathed through her mouth, in her mask (she had just put). Type of medical attention: benadryl co. + o2; emergency transportation to the hospital; spent several hours waiting, did not see a doctor. Symptoms: prickling in the throat; acute and sudden respiratory difficulty; red plaques on the neck; sweating and nausea occurred 1 min after inhaling through the mouth into the new mask. Duration of the adverse reaction: 1 hour.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611959-2018-00005 |
| MDR Report Key | 8003198 |
| Report Source | FOREIGN |
| Date Received | 2018-10-24 |
| Date of Report | 2018-10-24 |
| Date of Event | 2018-10-01 |
| Date Mfgr Received | 2018-10-04 |
| Date Added to Maude | 2018-10-24 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DOMINIQUE ABECASSIS |
| Manufacturer Street | 2555 CHEMIN DE L'AVIATION |
| Manufacturer City | POINTE-CLAIRE (MONTREAL), QUEBEC H9P 2Z2 |
| Manufacturer Country | CA |
| Manufacturer Postal | H9P 2Z2 |
| Manufacturer G1 | UNITED MEDICAL ENTERPRISES |
| Manufacturer Street | 4949 ALLEN STATION ROAD |
| Manufacturer City | AUGUSTA GA 30906 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30906 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDICOM SAFEMASK PREMIER ELITE |
| Generic Name | MASK |
| Product Code | FXX |
| Date Received | 2018-10-24 |
| Returned To Mfg | 2018-10-17 |
| Catalog Number | 2046 |
| Lot Number | (10)1815 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-10-24 |