MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-27 for CORRECT PLUS IMPRESSION MATERIAL Q34HA manufactured by Pentron / Kerr Corporation.
[115563869]
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 patient's dental caps.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078670 |
| MDR Report Key | 7731110 |
| Date Received | 2018-07-27 |
| Date of Report | 2018-07-24 |
| Date of Event | 2018-07-23 |
| Date Added to Maude | 2018-07-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CORRECT PLUS IMPRESSION MATERIAL |
| Generic Name | IMPRESSION MATERIAL |
| Product Code | ELW |
| Date Received | 2018-07-27 |
| Catalog Number | Q34HA |
| Lot Number | 6270440 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PENTRON / KERR CORPORATION |
| Manufacturer Address | ORANGE CA 92867 US 92867 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-27 |