MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2010-09-02 for TRANSBOND SEP, TRANSBOND PLUS CC ADHESIVE 712-090/1, 712-104 manufactured by 3m Unitek.
[14928103]
Orthodontist reported that pt's dermatologist had determined that pt is allergic to dimethylacrylates. Orthodontist stated that pt did not include in her medical history that she is allergic to acrylics. Pt reported to the mfr that she had a severe systemic allergic reaction to the orthodontic adhesive after the rebonding of some orthodontic brackets that had detached. Pt said that she has recovered from the reaction. Orthodontist stated that pt is continuing her orthodontic treatment.
Patient Sequence No: 1, Text Type: D, B5
[15169219]
The instructions-for-use for transbond plus color change adhesive contains the following warning: transbond plus color change adhesive contains acrylate monomers. 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 the 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. The instructions-for-use for transbond plus self etching primer contains the following warning: possible acrylic sensitivity - this product contains acrylates which cause allergic reaction in some individuals.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020467-2010-00006 |
| MDR Report Key | 1827698 |
| Report Source | 99 |
| Date Received | 2010-09-02 |
| Date of Report | 2010-08-11 |
| Date of Event | 2010-07-01 |
| Date Mfgr Received | 2010-08-11 |
| Date Added to Maude | 2010-09-10 |
| 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 |
| Reporter Occupation | DENTIST |
| 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 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSBOND SEP, TRANSBOND PLUS CC ADHESIVE |
| Generic Name | ORTHODONTIC PRIMER AND ADHESIVE |
| Product Code | DYH |
| Date Received | 2010-09-02 |
| Model Number | NA |
| Catalog Number | 712-090/1, 712-104 |
| Lot Number | UNK |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M UNITEK |
| Manufacturer Address | 2724 SOUTH PECK RD. MONROVIA CA 91016 US 91016 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-09-02 |