MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-30 for CORRECT PLUS Q34HA manufactured by Pentron Clinical.
[118902897]
No patient information was provided in regards to age, sex, weight, ethnicity, and race. No name or contact information was provided from the initial reporter. Initial reporter sent report to fda with reference number mw5078670. The product was not returned; however, the retain sample was evaluated yielding results that meet the required specifications.
Patient Sequence No: 1, Text Type: N, H10
[118902898]
A complainant alleged that dental putty was being used to create a custom bite block for rad oncology simulation treatment. After several attempts were made to remove the bite block, it came loose, but also removed three of the patients dental caps.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024312-2018-00002 |
| MDR Report Key | 7835006 |
| Date Received | 2018-08-30 |
| Date of Report | 2018-08-30 |
| Date of Event | 2018-07-23 |
| Date Mfgr Received | 2018-08-30 |
| Device Manufacturer Date | 2017-03-10 |
| Date Added to Maude | 2018-08-30 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PAULO CALLE |
| Manufacturer Street | 1717 W COLLINS AVENUE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer G1 | PENTRON CLINICAL |
| Manufacturer Street | 1717 W 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 | 0 |
| Brand Name | CORRECT PLUS |
| Generic Name | IMPRESSION MATERIAL |
| Product Code | ELW |
| Date Received | 2018-08-30 |
| Catalog Number | Q34HA |
| Lot Number | 6270440 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PENTRON CLINICAL |
| Manufacturer Address | 1717 W COLLINS AVENUE ORANGE CA 92867 US 92867 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-30 |