APC PLUS ADHESIVE
Report
- Report Number
- 2020467-2007-00002
- Event Type
- Injury
- Date Received
- June 7, 2007
- Date of Event
- February 28, 2007
- Report Date
- May 14, 2007
- Manufacturer
- 3M UNITEK
- Product Code
- DYW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LU
- Reporter Occupation
- OTHER
Narratives
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.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APC PLUS ADHESIVE | ORTHODONTIC ADHESIVE | DYW | 3M UNITEK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention | ARCHWIRES| ORTHODONTIC METAL AND CERAMIC BRACKETS |