MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-03-26 for MULTI-CURE GLASS IONOMER BAND CEMENT 712-050 manufactured by 3m Unitek.
[18328249]
Registered dental assistant (rda) reported that patient had a reaction consistent with contact dermatitis after a band was re-cemented on pt's tooth. Rda reported that at the beginning of patient's orthodontic treatment, patient experienced mild irritaion when the bands were initially cemented on their teeth. Subsequently, on two separate occasions when a band had to be re-cemented, patient experienced increased dermatitis with each occasion. In 2004, when patient had another band re-cemented, they experienced a red, inflamed a rash and puffy lips. Orthodontist removed the band and patient's pediatrician prescribed a steriod (prednisone) for reaction. Patient has completely recovered from the reaction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2004-00004 |
| MDR Report Key | 517968 |
| Report Source | 05 |
| Date Received | 2004-03-26 |
| Date of Report | 2004-03-16 |
| Date of Event | 2004-03-13 |
| Date Mfgr Received | 2004-03-16 |
| Date Added to Maude | 2004-03-30 |
| 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 ROAD |
| Manufacturer City | MONRONIVA CA 91016 |
| Manufacturer Country | US |
| Manufacturer Postal | 91016 |
| Manufacturer Phone | 6265744496 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTI-CURE GLASS IONOMER BAND CEMENT |
| Generic Name | ORTHODONTC BAND CEMENT |
| Product Code | DYH |
| Date Received | 2004-03-26 |
| Model Number | NA |
| Catalog Number | 712-050 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 507003 |
| Manufacturer | 3M UNITEK |
| Manufacturer Address | 2724 SOUTH PECK RD. MONROVIA CA 91016 US |
| Baseline Brand Name | MULTI-CURE GI CEMEMT KIT |
| Baseline Generic Name | GLASS IONOMER BAND CEM |
| Baseline Model No | 712-050 |
| Baseline Catalog No | 712-050 |
| Baseline ID | NONE |
| Baseline Device Family | GLASS IONOMER CEMENT/ADHESIVE |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K950514 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-03-26 |