MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-25 for SENOMARK ULTRA BREAST TISSUE MARKER SMEC10C manufactured by Bard Peripheral Vascular, Inc..
[185228073]
As the lot number for the device was not provided, a manufacturing review could not be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Patient Sequence No: 1, Text Type: N, H10
[185228094]
It was reported that post breast tissue marker placement through hard tissue, the patient allegedly experienced total body itching. Reportedly, the physician is planning to remove the device. The patient status is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2020-02019 |
| MDR Report Key | 9880947 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2017-11-07 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-25 |
| 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 | JUDITH LUDWIG |
| Manufacturer Street | 1415 W. 3RD STREET |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | INFUS MEDICAL (THAILAND) |
| Manufacturer Street | 706 MOO 4 BANGPOO IND ESTATE |
| Manufacturer City | SAMUTPRAKARN PROVINCE 10280 |
| Manufacturer Country | TH |
| Manufacturer Postal Code | 10280 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENOMARK ULTRA BREAST TISSUE MARKER |
| Generic Name | BIOPSY INSTRUMENT |
| Product Code | NEU |
| Date Received | 2020-03-25 |
| Model Number | SMEC10C |
| Catalog Number | SMEC10C |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | 1625 W 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |