MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-15 for GUTTAFUSION PINK OBTURATOR V041532000025 manufactured by Dentsply Vdw Gmbh.
[60423929]
While it is unknown if the guttafusion obturator caused or contributed to the patient's symptoms, it cannot be definitively ruled out. Therefore, this event is reportable per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
[60423930]
In this event it was reported that a patient experienced swelling and pain all over the face after a root canal treatment where several different products, including a guttafusion obturator, was used. The patient saw a physician and was treated with antibiotics and analgesics. According to the dentist there was no overfilling and sealing was performed. The patient has no history of allergy is doing well now.
Patient Sequence No: 1, Text Type: D, B5
[60450328]
Charger and file clip not received. Apex locator checked with test box (b)(4) without errors.
Patient Sequence No: 1, Text Type: N, H10
[65287087]
Customer returned one unopened sleeve ((b)(4) pcs) of size r25, lot 0000122780, which is indicated as the lot matching this complaint. Customer also returned 2 additional packs containing size r40, lot 0000105559 and size r50, lot 0000092885. None of the obturators had been opened. No loose or opened obturators were returned. Visually checked obturators and found no fault with the obturators returned. Follow-up #1 was submitted in error and does not pertain to this mfr report number.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611053-2016-00057 |
| MDR Report Key | 5501625 |
| Date Received | 2016-03-15 |
| Date of Report | 2017-01-19 |
| Date of Event | 2016-10-13 |
| Date Mfgr Received | 2017-01-04 |
| Date Added to Maude | 2016-03-15 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494229 |
| Manufacturer G1 | DENTSPLY TULSA DENTAL SPECIALTIES |
| Manufacturer Street | 608 ROLLING HILLS DRIVE |
| Manufacturer City | JOHNSON CITY TN 37604 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GUTTAFUSION PINK OBTURATOR |
| Generic Name | GUTTA-PERCHA |
| Product Code | EKM |
| Date Received | 2016-03-15 |
| Model Number | NA |
| Catalog Number | V041532000025 |
| Lot Number | 158540 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY VDW GMBH |
| Manufacturer Address | BAYERWALDSTRASSE 15 MUNICH, 81737 GM 81737 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-03-15 |