MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-25 for N-TRALIG INTRLGMNTRY SYRG 76-55 manufactured by Integra York, Pa Inc..
[91198573]
10/16/17 integra investigation completed. Method: failure analysis, device history evaluation results: failure analysis - the customer supplied pictures indicate necrotic tissue at injection site. The cause for the necrotic tissue can not be determined as the needle, lidocaine, and process during the procedure is not known. The complaint is confirmed. Device history evaluation - any applicable nonconforming product report / nonconforming material report history: none. Any applicable variance authorization / deviation history: none. Any applicable engineering change order / manufacturing change order history: none. Any applicable corrective action preventive action history: none. Health hazard evaluation history: none. Conclusion: the customer supplied pictures indicate necrotic tissue at injection site. Root cause undetermined. There has been no manufacturing deficiency identified.
Patient Sequence No: 1, Text Type: N, H10
[91198574]
Doctor initially reports the syringe created necrotic tissue at the injection site. On (b)(6) 2017 doctor reports anesthetic used: septocaine 1:200,000 - approximately 1/3-1/2 carpule injected at cervical of facial surface of tooth at gum line under pressure at 3 sites mesial proximal, facial, distal proximal. Chlorhexidine rinse cleared up the area. Area resolved without further incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2017-00120 |
| MDR Report Key | 6975447 |
| Date Received | 2017-10-25 |
| Date of Report | 2017-10-05 |
| Date of Event | 2017-08-28 |
| Date Mfgr Received | 2017-10-05 |
| Date Added to Maude | 2017-10-25 |
| 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 | USER SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | N-TRALIG INTRLGMNTRY SYRG |
| Generic Name | M51 - GENERAL DENTISTRY |
| Product Code | EJI |
| Date Received | 2017-10-25 |
| Catalog Number | 76-55 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-25 |