MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-06-07 for APC PLUS ADHESIVE SEE H10 manufactured by 3m Unitek.
[669532]
After starting orthodontic treatment, pt developed a reaction, which consisted of itching on the head and neck. Subsequent tests showed that the pt is allergic to methacrylates, gold, and mercury. Pt wear gold jewelry and has amalgam restorations in her teeth. The apc plus adhesive precoated orthodontic brackets used in the pt's orthodontic treatment contain methacrylates. Pt was given antihistamines to control the itching and continues her orthodontic treatment (the orthodontic brackets have not been removed from the pt's mouth). Instruction -for use for apc plus adhesive coated orthodontic brackets contains the following warning: acrylate monomers are known to produce allergic skin reactions in certain sensitive individuals. May cause eye and skin irritation. Precautions: avoid eye and skin contact. Wear gloves when handling this material. First aid: eye contact: immediately flush with plenty of water. See a physician if irritation persists. Skin contact: wash affected area with soap and water. See a physician if irritation persists.
Patient Sequence No: 1, Text Type: D, B5
[7981100]
Catalog #: 5017-519, 5017-661, 5017-662, 5017-669, 5017-670, 5017-675, 5017-676, 5017-679, 5017-680, 5017-683, 5017-686, 5017-689, 6800-751, 6800-572, 6800-753, 6800-754, 6800-755, 6800-756, 6800-757, 6800-758, 6800-761,6800-762, 6800-774, 6800-775, 6800-776, 6800-924.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020467-2007-00002 |
| MDR Report Key | 863219 |
| Report Source | 05 |
| Date Received | 2007-06-07 |
| Date of Report | 2007-05-14 |
| Date of Event | 2007-02-28 |
| Date Mfgr Received | 2007-05-14 |
| Date Added to Maude | 2007-06-15 |
| 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 | MARLYN SCHEFF |
| Manufacturer Street | 2724 SOUTH PECK RD. |
| Manufacturer City | MONROVIA CA 91016 |
| Manufacturer Country | US |
| Manufacturer Postal | 91016 |
| Manufacturer Phone | 6265744496 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APC PLUS ADHESIVE |
| Generic Name | ORTHODONTIC ADHESIVE |
| Product Code | DYW |
| Date Received | 2007-06-07 |
| Model Number | NA |
| Catalog Number | SEE H10 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 847209 |
| Manufacturer | 3M UNITEK |
| Manufacturer Address | 2724 SOUTH PECK RD. MONROVIA CA 91016 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-06-07 |