MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-07-29 for NEOBAND LIGHT CURE BAND CEMENT 52-800-52 manufactured by Gac International.
[6255988]
In this event a dentist reported that they were having issues with neoband cement running out of the band and it went into the gums of a patient and caused an infection.
Patient Sequence No: 1, Text Type: D, B5
[14305589]
Multiple unsuccessful attempts were made to obtain additional information. However, since an infection would likely result in the need for intervention, this event is reportable per 21 cfr part 803. The device was evaluated and found to be within specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2418500-2015-00002 |
| MDR Report Key | 4961222 |
| Report Source | 05 |
| Date Received | 2015-07-29 |
| Date of Report | 2015-03-13 |
| Date Mfgr Received | 2015-03-13 |
| Date Added to Maude | 2015-08-04 |
| 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 | HELEN LEWIS |
| Manufacturer Street | SUSQUEHANNA COMMERCE CTR W. 221 W. PHILADELPHIA ST., STE. 60 |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOBAND LIGHT CURE BAND CEMENT |
| Generic Name | BRACKET ADHESIVE RESIN |
| Product Code | DYH |
| Date Received | 2015-07-29 |
| Returned To Mfg | 2015-03-24 |
| Catalog Number | 52-800-52 |
| Lot Number | 4138-07ID1ABCK |
| Device Expiration Date | 2016-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAC INTERNATIONAL |
| Manufacturer Address | ISLANDIA NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-29 |