MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-04-30 for BIOCCLUS KISS 5313190002 manufactured by Degudent Gmbh.
[4475819]
In this event it was reported that three days after inserting an implant-supported bridge made with biocclus kiss and duceram kiss, a patient reported they had a swelling and a metallic taste in their mouth. The bridge was immediately removed. The customer stated that the bridge was not glaze-burned, but polished with a diamond paste and has not evaporated.
Patient Sequence No: 1, Text Type: D, B5
[11781447]
While it is unknown if the device used in this case caused or contributed to the patient's symptoms, itis 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 803. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review. Please note that while this product is not sold in the us, it is considered similar to products that are when taking into account composition and indications for use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681199-2014-00001 |
| MDR Report Key | 3800240 |
| Report Source | 01,05 |
| Date Received | 2014-04-30 |
| Date of Report | 2014-03-31 |
| Date Mfgr Received | 2014-03-31 |
| Date Added to Maude | 2014-05-09 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST. STE. 60 SUSQUEHANNA COMMERCE CENTER W. |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOCCLUS KISS |
| Generic Name | ALLOY, GOLD-BASED NOBLE METAL |
| Product Code | EJT |
| Date Received | 2014-04-30 |
| Catalog Number | 5313190002 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEGUDENT GMBH |
| Manufacturer Address | HANAU/WOLFGANG GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-04-30 |