MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-11-12 for THERMASEAL PLUS TSLPLUS manufactured by Dentsply Tulsa Dental Specialties.
[5046469]
In this event a dentist reported that he had a pt who developed cysts 4 years after using thermaseal plus. The event outcome is unk as of this mdr eval.
Patient Sequence No: 1, Text Type: D, B5
[12551105]
Additional info has been requested, but is not yet available. However, because this event may have resulted in a serious injury, it meets the criteria for reportability per 21 cfr part 803. Because the device was used 4 years ago, it is not available for return, nor is the lot number available for retained-product testing and/or dhr review. Additional info regarding the pt outcome has been requested and will be submitted as it becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010638-2014-00009 |
| MDR Report Key | 4257326 |
| Report Source | 05 |
| Date Received | 2014-11-12 |
| Date of Report | 2014-10-13 |
| Date Mfgr Received | 2014-10-13 |
| Date Added to Maude | 2014-11-19 |
| 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 | 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 | THERMASEAL PLUS |
| Generic Name | RESIN, ROOT CANAL FILLING |
| Product Code | KIF |
| Date Received | 2014-11-12 |
| Catalog Number | TSLPLUS |
| 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 | DENTSPLY TULSA DENTAL SPECIALTIES |
| Manufacturer Address | JOHNSON CITY TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-11-12 |