MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-11 for HYDROMARK BREAST BIOPSY SITE MARKER 4010-02-15-T3 manufactured by Devicor Medical Products, Inc.
[189054925]
The hydromark breast biopsy site marker is used to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and mri. It was reported that after an ultrasound biopsy with a hydromark marker, product code (b)(4), caused a reaction in the patient. The patient is allergic to another compound similar to peg. No testing on the specific device has been conducted as the device was not returned for evaluation. However, sensitivity, cytoxicity and other reaction testing was conducted as part of the initial qualification of this device. No known reactions similar to those reported in this event were reported during this testing. Although it could not be concluded that our device caused or contributed to this event, due to the reported adverse event this has been determined to be reportable pursuant to 21 cfr 803. As such, we are submitting this medwatch report.
Patient Sequence No: 1, Text Type: N, H10
[189054926]
It was reported by sales rep after procedure, us modality, hydromark apparently caused a reaction in a patient. The patient is allergic to another compound similar to peg. This incident has been recorded in complaint # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008492462-2019-00053 |
| MDR Report Key | 9579348 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-11 |
| Date of Report | 2020-01-10 |
| Date of Event | 2019-12-11 |
| Date Mfgr Received | 2019-12-13 |
| Date Added to Maude | 2020-01-11 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JACK CUMMINGS |
| Manufacturer Street | 300 E BUSINESS WAY FIFTH FLOOR |
| Manufacturer City | CINCINNATI OH 45241 |
| Manufacturer Country | US |
| Manufacturer Postal | 45241 |
| Manufacturer G1 | DEVICOR MEDICAL PRODUCTS DE MEXICO |
| Manufacturer Street | SOR JUANAINES DE LA CRUZ #20152 4-B |
| Manufacturer City | PARQUE INDUSTRIAL, 22440 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22440 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYDROMARK BREAST BIOPSY SITE MARKER |
| Generic Name | BIOPSY SITE IDENTIFIER |
| Product Code | NEU |
| Date Received | 2020-01-11 |
| Model Number | 4010-02-15-T3 |
| Catalog Number | 4010-02-15-T3 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEVICOR MEDICAL PRODUCTS, INC |
| Manufacturer Address | 300 E. BUSINESS WAY FIFTH FLOOR CINCINNATI OH 45241 US 45241 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-11 |