MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-04-07 for V3 RING UNIVERSAL 403344 manufactured by Dentsply (n.z.) Limited.
[72128988]
Therefore, because medical intervention was required to preclude a serious injury, this event is reportable per 21cfr part 803. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Patient Sequence No: 1, Text Type: N, H10
[72128989]
It was reported that a v3 triodent universal ring was swallowed by a patient during a dental procedure. The clinician did not use a rubber dam as recommended per the ifu. The patient was sent to a gi specialist who retrieved the ring with an endoscope.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003959465-2017-00001 |
| MDR Report Key | 6472663 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-04-07 |
| Date of Report | 2017-04-07 |
| Date Mfgr Received | 2017-03-10 |
| Date Added to Maude | 2017-04-07 |
| 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 | 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 | 7178457551 |
| Manufacturer G1 | DENTSPLY (N.Z.) LIMITED |
| Manufacturer Street | 11 MARSHALL ROAD |
| Manufacturer City | KATIKATI, 3129 |
| Manufacturer Country | NZ |
| Manufacturer Postal Code | 3129 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | V3 RING UNIVERSAL |
| Generic Name | INSTRUMENTS, DENTAL HAND |
| Product Code | DZN |
| Date Received | 2017-04-07 |
| Model Number | NA |
| Catalog Number | 403344 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY (N.Z.) LIMITED |
| Manufacturer Address | 11 MARSHALL ROAD KATIKATI, 3129 NZ 3129 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-04-07 |