MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-03 for NTI INTER FLEX DS DIAMOND DISC D943-100 manufactured by Nti-kahla Gmbh.
[113156139]
An alleged complaint was reported that the diamond disc shattered and penetrated the patients lip. Staff applied compression, flushed the area and sutured the wound close. The patient required a total of 7 stitches. Patient had swelling with bruising on their lip during a follow up. Patients lip is healing, but there is scar tissue. No other complaints and or complication reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1645240-2018-00001 |
| MDR Report Key | 7661568 |
| Date Received | 2018-07-03 |
| Date of Report | 2018-10-12 |
| Date of Event | 2018-06-04 |
| Date Facility Aware | 2018-06-05 |
| Report Date | 2018-07-06 |
| Date Reported to FDA | 2018-07-03 |
| Date Reported to Mfgr | 2018-07-06 |
| Date Added to Maude | 2018-07-03 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NTI INTER FLEX DS DIAMOND DISC |
| Generic Name | INSTRUMENT, DIAMOND, DENTAL |
| Product Code | DZP |
| Date Received | 2018-07-03 |
| Catalog Number | D943-100 |
| Operator | DENTIST |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NTI-KAHLA GMBH |
| Manufacturer Address | IM CAMISCH 3 KAHLA, D-07768 GM D-07768 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-03 |