MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-08-14 for ORTHO WAX ORTHO WX 2PK CD manufactured by Ranir Llc.
[82622108]
Allergic reaction; his throat was swelling up and he had problems breathing. Was listed. Within 20 minutes he was coughing cause he couldn't breathe. He took benadryl and he was ok.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825660-2017-00133 |
| MDR Report Key | 6792406 |
| Report Source | CONSUMER |
| Date Received | 2017-08-14 |
| Date of Report | 2017-07-17 |
| Date of Event | 2017-07-12 |
| Date Facility Aware | 2017-07-17 |
| Date Mfgr Received | 2017-07-17 |
| Date Added to Maude | 2017-08-14 |
| 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 | MRS BRENDA MUMBOWER |
| Manufacturer Street | 4701 EAST PARIS AVE SE |
| Manufacturer City | GRAND RAPIDS MI 49512 |
| Manufacturer Country | US |
| Manufacturer Postal | 49512 |
| Manufacturer Phone | 6166988880 |
| Manufacturer G1 | RANIR LLC |
| Manufacturer Street | 4701 EAST PARIS AVE SE |
| Manufacturer City | GRAND RAPIDS MI 49512 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHO WAX |
| Generic Name | WAX, DENTAL, INTRAORAL |
| Product Code | EGD |
| Date Received | 2017-08-14 |
| Model Number | ORTHO WX 2PK CD |
| Lot Number | 160510M |
| Operator | DEVICE UNATTENDED |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RANIR LLC |
| Manufacturer Address | 4701 EAST PARIS AVE SE GRAND RAPIDS MI 495125353 US 495125353 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-14 |