MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-07-03 for ZOO PACK ELASTICS 636-0122 manufactured by Ormco Corporation.
[2828846]
A doctor alleged that a patient developed an allergic reaction in the form of irritated and swollen gums after placement of the bear zoo pack elastics intraoral elastics in the color 'purple'.
Patient Sequence No: 1, Text Type: D, B5
[9971157]
The patient was advised by the doctor to take over-the-counter benadryl for her symptoms. To date, the patient is doing fine; the 'purple' elastic bands were replaced with the 'clear' intraoral bands, which were previously used without incident. The product was returned and no lot number was provided; therefore, no investigation can be conducted.
Patient Sequence No: 1, Text Type: N, H10
[15624178]
The product involved in the alleged incident was not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2012-00017 |
| MDR Report Key | 2639023 |
| Report Source | 05 |
| Date Received | 2012-07-03 |
| Date of Report | 2012-06-04 |
| Date of Event | 2012-06-04 |
| Date Mfgr Received | 2012-06-04 |
| Date Added to Maude | 2012-07-05 |
| 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. WENDY GARMAN |
| Manufacturer Street | 1717 WEST COLLINS AVENUE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167602 |
| 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 | ZOO PACK ELASTICS |
| Generic Name | BAND, ELASTIC, ORTHODONTIC |
| Product Code | ECI |
| Date Received | 2012-07-03 |
| Catalog Number | 636-0122 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORPORATION |
| Manufacturer Address | 1332 SOUTH LONE HILLS AVENUE GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2012-07-03 |