MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-12-17 for A.D. PROTRACTION FACEMASK 716-0001 manufactured by Ormco Corporation.
[130542674]
It was alleged that a. D. Protraction facemask has made a patient very ill; however, no further specific information or product has been received at this time. Upon further information received we will send an update.
Patient Sequence No: 1, Text Type: N, H10
[130542675]
It is alleged that a. D. Protraction facemask has made a patient very ill.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2018-00061 |
| MDR Report Key | 8170567 |
| Report Source | OTHER |
| Date Received | 2018-12-17 |
| Date of Report | 2018-12-07 |
| Date Mfgr Received | 2018-12-10 |
| Date Added to Maude | 2018-12-17 |
| 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. SUZETTE RAMPAIR-JOHNSON |
| Manufacturer Street | 1332 SOUTH LONE HILL AVE. |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal | 91740 |
| Manufacturer Phone | 9096713431 |
| Manufacturer G1 | ORMCO CORPORATION |
| Manufacturer Street | 1332 SOUTH LONE HILL AVE. |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91740 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | A.D. PROTRACTION FACEMASK |
| Generic Name | A.D. PROTRACTION FACEMASK |
| Product Code | DZB |
| Date Received | 2018-12-17 |
| Catalog Number | 716-0001 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORPORATION |
| Manufacturer Address | 1332 SOUTH LONE HILL AVE. GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-17 |