MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-27 for DENTAL COLLAGEN IMPLANT manufactured by .
[78678253]
Dentist extracted caller's tooth and implanted a collagen device to assist with healing. Caller stated he began to experience a reaction post extraction; rash, redness, itching, irritation, and blisters across the chest. After the reaction spread, caller went to the emergency room, received a steroid shot and headed home. The next morning, caller woke up with redness and a burning sensation. He contacted his dentist and was told the reaction cannot be due to the implant because it is a "natural product". Caller looked online and found testimonials of other people's reaction to the implant. Caller stated his reaction has decreased drastically but worried about possible reaction after medications are finished.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070670 |
| MDR Report Key | 6673096 |
| Date Received | 2017-06-27 |
| Date of Report | 2017-06-27 |
| Date of Event | 2017-06-21 |
| Date Added to Maude | 2017-06-28 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | PATIENT |
| 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 | DENTAL COLLAGEN IMPLANT |
| Generic Name | DENTAL COLLAGEN IMPLANT |
| Product Code | MGQ |
| Date Received | 2017-06-27 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-27 |