MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-11-19 for MULTI CURE GI BAND CEMENT 712-050 manufactured by 3m Unitek.
[970321]
During a regular scheduled orthodontic appointment, an adjustment was made to patient's upper archwire, and an alginate impression was also done in order to fabricate a lower bonded lingual retainer. After adjusting the upper archwire, the hygienist noted a loose band on the patient's lower right second molar tooth. During the procedure of cementing the band to the patient's molar with multi cure gi band cement, patient indicated that she was having difficulty breathing and informed the orthodontic staff that she needed her epipen. Patient's mother administered the epipen to patient. After about 15 minutes of observation, patient's mother took her to an urgent care clinic for further observation and examination. Orthodontist advised that the patient is okay at this time.
Patient Sequence No: 1, Text Type: D, B5
[8133791]
The instructions-for-use for multi-cure glass ionomer orthodontic band cement contain the following warning: "warning: liquid contains hema (2-hydroxyethyl methacrylate). Hema is severely irritating to the eye and is a known contact allergen. A small percentage of the population is known to have an allergic response to acrylate resins. To reduce the risk of allergic response, minimize exposure to these materials. In particular, exposure to uncured resin should be avoided. Use of protective gloves and a no-touch technique is recommended. If skin contacts liquid or powder/liquid mix, wash skin immediately with soap and water. Acrylates may penetrate commonly used gloves. If glove contacts liquid or power/liquid mix, remove and discard glove, wash hands immediately with soap and water, and then reglove. Liquid and powder/liquid mix may cause eye irritation upon contact and may be mildly irritating to oral soft tissue upon contact. Avoid contact with eyes and minimize contact with oral soft tissue. If contact with eyes occurs, flush immediately with large amounts of water. If irritation persists, consult at physician. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020467-2008-00003 |
| MDR Report Key | 1238409 |
| Report Source | 05 |
| Date Received | 2008-11-19 |
| Date of Report | 2008-10-30 |
| Date of Event | 2008-10-28 |
| Date Mfgr Received | 2008-10-30 |
| Date Added to Maude | 2009-01-29 |
| 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 | 3 |
| 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 | MULTI CURE GI BAND CEMENT |
| Generic Name | ORTHODONTIC ADHESIVE |
| Product Code | DYH |
| Date Received | 2008-11-19 |
| Model Number | NA |
| Catalog Number | 712-050 |
| Lot Number | UNK |
| 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 | 2724 SOUTH PECK RD. MONROVIA CA 91016 US 91016 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-11-19 |