MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-07-16 for MAXCEM ELITE 33872 manufactured by Kerr Corporation.
[19607553]
A dental office alleged that a patient had experienced blistering and redness after restorative cementation procedures were completed using the maxcem elite clear product.
Patient Sequence No: 1, Text Type: D, B5
[20136312]
A doctor alleged that following placement of a crown using maxcem elite a patient experienced blistering and redness around the gums and on the adjacent cheek area. The patient was prescribed antibiotics. The doctor will monitor the patient's condition. Despite requests for additional information, current patient status is unknown. The product involved in the alleged incident(s) was not returned; therefore, a retain sample was evaluated, yielding results within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2024312-2015-00018 |
| MDR Report Key | 4917376 |
| Report Source | 05 |
| Date Received | 2015-07-16 |
| Date of Report | 2015-06-30 |
| Date of Event | 2015-06-29 |
| Date Mfgr Received | 2015-06-30 |
| Date Added to Maude | 2015-07-16 |
| 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 | MR. MARK DZENDZEL |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167802 |
| Manufacturer G1 | KERR CORPORATION |
| Manufacturer Street | 1717 WEST COLLINS AVENUE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92867 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAXCEM ELITE |
| Generic Name | CEMENT, DENTAL |
| Product Code | MZW |
| Date Received | 2015-07-16 |
| Catalog Number | 33872 |
| Lot Number | 5454215 |
| Device Expiration Date | 2016-09-30 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KERR CORPORATION |
| Manufacturer Address | 1717 WEST COLLINS AVENUE ORANGE CA 92867 US 92867 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-16 |