MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-15 for ANTHEM GENERATOR ANTHEM 40-500 110-5120G11 manufactured by Del Medical Inc..
[142063699]
During a recent fda investigation it was observed that we chose not to submit a medical device report for this customer complaint as the complaint could not be substantiated by our investigation. We are dutifully submitting this report as part of the conclusion for this observation.
Patient Sequence No: 1, Text Type: N, H10
[142063700]
The operator reported to her manager that after or during an xray exposure she heard a bang noise and felt some kind of shock.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418964-2019-00015 |
| MDR Report Key | 8513770 |
| Date Received | 2019-04-15 |
| Date of Report | 2019-04-15 |
| Date of Event | 2016-04-28 |
| Date Mfgr Received | 2016-04-28 |
| Device Manufacturer Date | 2014-07-07 |
| Date Added to Maude | 2019-04-15 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. WILLIAM KOSTECKI |
| Manufacturer Street | 241 COVINGTON DRIVE |
| Manufacturer City | BLOOMINGDALE IL 60108 |
| Manufacturer Country | US |
| Manufacturer Postal | 60108 |
| Manufacturer Phone | 8472887022 |
| Manufacturer G1 | DEL MEDICAL INC. |
| Manufacturer Street | 241 COVINGTON DRIVE |
| Manufacturer City | BLOOMINGDALE IL 60108 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60108 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ANTHEM GENERATOR |
| Generic Name | RADIOGRAPHIC GENERATOR |
| Product Code | IZO |
| Date Received | 2019-04-15 |
| Model Number | ANTHEM 40-500 |
| Catalog Number | 110-5120G11 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEL MEDICAL INC. |
| Manufacturer Address | 241 COVINGTON DRIVE BLOOMINGDALE IL 60108 US 60108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-04-15 |