MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-08 for THORNTON ADJUSTABLE POSITIONER AM ALIGNER manufactured by Airway Mgmt Inc.
[116789970]
Patient wore medical device for the first time. Within 2 hours of wearing it, he developed red rash on his extremities, burning sensation, tongue swelling, metallic taste, palpitations. He went to the local emergency department after calling the advice nurse. He was given epinephrine injection and noted rapid improvement in his symptoms. He was also treated with iv solumedrol, benadryl and pepcid. He was discharged after 3 hours of observation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078991 |
| MDR Report Key | 7769199 |
| Date Received | 2018-08-08 |
| Date of Report | 2018-08-06 |
| Date of Event | 2018-07-15 |
| Date Added to Maude | 2018-08-09 |
| 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 |
| 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 | THORNTON ADJUSTABLE POSITIONER AM ALIGNER |
| Generic Name | POSITIONER, TOOTH PREFORMED |
| Product Code | KMY |
| Date Received | 2018-08-08 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AIRWAY MGMT INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-08 |