MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-07-13 for HYDRORISE LIGHT BODY NORMAL SET C207000 manufactured by Zhermack S.p.a..
[113907725]
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. The device was not returned for evaluation. However, the lot number was provided and retained-product testing and/or dhr review are planned. The results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
[113907726]
It was reported that a patient experienced an allergic reaction after the use of hydrorise light body impression material. The symptoms include burning, sloughing and slight inflammation of the patient's lip. It is unknown if the patient required any medical intervention. Additional information has been requested, but is not yet available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614794-2018-00002 |
| MDR Report Key | 7685392 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-07-13 |
| Date of Report | 2018-08-27 |
| Date Mfgr Received | 2018-08-01 |
| Date Added to Maude | 2018-07-13 |
| 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 | MRS. HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494229 |
| 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 | HYDRORISE LIGHT BODY NORMAL SET |
| Generic Name | MATERIAL, IMPRESSION |
| Product Code | ELW |
| Date Received | 2018-07-13 |
| Model Number | NA |
| Catalog Number | C207000 |
| Lot Number | 275761 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-07-13 |