MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-04-11 for HIGH PULL HEADGEAR 715-1011 manufactured by Ormco Corporation.
[21167404]
It was reported by the doctor that the patient sought medical attention with a dermatologist and was given a cream for the reaction. To date, the patient is doing fine. The product was not returned and no lot number was provided; therefore, no evaluations can be conducted.
Patient Sequence No: 1, Text Type: N, H10
[21241773]
A doctor alleged that a patient had experienced irritation, friction and pain after wearing the high pull headgear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2014-00026 |
| MDR Report Key | 3746520 |
| Report Source | 05 |
| Date Received | 2014-04-11 |
| Date of Report | 2014-03-17 |
| Date Mfgr Received | 2014-03-17 |
| Date Added to Maude | 2014-04-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. KERRI CASINO |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167634 |
| Manufacturer G1 | ORMCO CORPORATION |
| Manufacturer Street | 1332 SOUTH LONE HILL AVENUE |
| 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 | HIGH PULL HEADGEAR |
| Generic Name | EXTRAORAL ORTHODONTIC HEADGEAR |
| Product Code | DZB |
| Date Received | 2014-04-11 |
| Catalog Number | 715-1011 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORPORATION |
| Manufacturer Address | 1332 SOUTH LONE HILL AVENUE GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2014-04-11 |