MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-12-05 for UNITEK MULTICURE BI BAND CEMENT, APC II 712-050, 3024-875 manufactured by 3m Unitek.
[5180027]
On (b)(6) 2014-installed two 3m stainless steel molar bands using unitek multi cure glass ionomer orthodontic band cement. Also installed a gac lip bumper; (b)(6) 2014 - installed upper 5x5 3m prepasted metal brackets; (b)(6) 2014 - checked lip bumper, all appeared ok; (b)(6) 2014 - patient seen at immunologist for dermatitis, blistering, redness of lips and gums. Prescribed mometasone, which seemed to help; (b)(6) 2014 - patient returned to orthodontist and all components were removed. Multiple items prepared for patch testing; (b)(6) 2014 - evaluation prepared by immunologist. Findings/suspicions somewhat preliminary with possible cross contamination in initial patch tests. Reactions were cited to pieces of the lip bumper nylon, the lip bumper wire, a gray band tie, and a sample of a 3m adhesive similar to that on the prepasted bracket. The prepasted bracket was not submitted for patch testing. The doctor's initial opinion was that the patient developed a sensitivity to methacrylate over time and that the non-adhesive samples may have had a residue ot the initial gi band cement or apc ii bracket adhesive.
Patient Sequence No: 1, Text Type: D, B5
[12619998]
Both the unitek multi cure glass ionomer orthodontic band cement and the apc ii adhesive-precoated brackets are labeled with a warning that the product contains acrylates, and that a certain percentage of the population is known to have an allergic response to acrylate resins.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020467-2014-00002 |
| MDR Report Key | 4338267 |
| Report Source | 05 |
| Date Received | 2014-12-05 |
| Date of Report | 2014-11-11 |
| Date of Event | 2014-09-01 |
| Date Mfgr Received | 2014-11-11 |
| Date Added to Maude | 2014-12-18 |
| 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 | KATHLEEN BACON |
| Manufacturer Street | 2724 SOUTH PECK RD. |
| Manufacturer City | MONROVIA CA 91016 |
| Manufacturer Country | US |
| Manufacturer Postal | 91016 |
| Manufacturer Phone | 6265744212 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNITEK MULTICURE BI BAND CEMENT, APC II |
| Generic Name | ADHESIVE, BRACKET/TOOTH COND, RESIN |
| Product Code | DYH |
| Date Received | 2014-12-05 |
| Model Number | NA |
| Catalog Number | 712-050, 3024-875 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 | MONROVIA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 3 | 1. Required No Informationntervention | 2014-12-05 |