MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2015-02-23 for VANTG AUTOCL PROPHY ANG. 75-30 manufactured by Integra York, Pa Inc.
[5525790]
Customer initially stated that black liquid comes out of the instrument while using it. On (b)(6) 2015, doctor reports this event does not occur when they run the device outside the mouth. There has been no harm to patient or black liquid swallowed. No specific patient event info.
Patient Sequence No: 1, Text Type: D, B5
[12936437]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2015-00006 |
| MDR Report Key | 4550611 |
| Report Source | 06,08 |
| Date Received | 2015-02-23 |
| Date of Report | 2015-01-28 |
| Date Mfgr Received | 2015-01-30 |
| Date Added to Maude | 2015-03-26 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA LEE |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VANTG AUTOCL PROPHY ANG. |
| Generic Name | M52- HYGIENE/PERIODONTAL |
| Product Code | EAX |
| Date Received | 2015-02-23 |
| Catalog Number | 75-30 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-23 |