MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-04-20 for CHROMACLONE COLORCHANGE B000082 manufactured by Zhermack S.p.a..
[73328958]
While it is unknown if the device used in this case caused or contributed to the patient's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material. Therefore, this event meets the criteria for reportability per 21 cfr part 803. Retained device was tested and found to be within specification.
Patient Sequence No: 1, Text Type: N, H10
[73328959]
It was reported that a patient experienced an allergic reaction after the use of chromaclone color change impression material. The symptoms reported include a rash from his stomach to neck, a sore neck and jaw, warm around the mouth, and shortness of breath. The patient took benadryl for relief.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614794-2017-00001 |
| MDR Report Key | 6509113 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-04-20 |
| Date of Report | 2017-04-20 |
| Date of Event | 2017-01-30 |
| Date Mfgr Received | 2017-02-03 |
| Date Added to Maude | 2017-04-20 |
| 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 | ZHERMACK S.P.A. |
| Manufacturer Street | VIA BOVAZECCHINO, 100 |
| Manufacturer City | BADIA POLESINE, 45021 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 45021 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHROMACLONE COLORCHANGE |
| Generic Name | MATERIAL, IMPRESSION |
| Product Code | ELW |
| Date Received | 2017-04-20 |
| Model Number | NA |
| Catalog Number | B000082 |
| Lot Number | 246267 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZHERMACK S.P.A. |
| Manufacturer Address | VIA BOVAZECCHINO, 100 BADIA POLESINE, 45021 IT 45021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-20 |