MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-05-31 for SECURMARK SMARK-U-SS2 manufactured by Hologic, Inc..
[146773363]
Lot and serial number of the disposable device not provided by the complainant, therefore the expiration date is not known. The device is not being returned therefore, a failure analysis of the complaint device cannot be completed. Lot number of the disposable device not provided by the complainant, therefore the manufacture date is not known. Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant. Internal complaint reference: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[146773364]
It was reported that a patient had a biopsy procedure on (b)(6) 2019 and a biopsy marker was placed. The patient reported that side effects started within 2 days of the procedure, " i felt little bursts behind nipple within the following day waking up to dark purple bruising; approximately 2 inch by 3 inch hard lump swelling; kidneys aching, joint pain and inflammation both arms and legs, lips tingling and swelling. I didn't have any of the symptoms prior to core biopsy and breast marker placement. " the patient has followed up with her physician regarding these symptoms. The patient declined to provide any information on the site where the biopsy was performed. The biopsy results were negative for malignancy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2019-00136 |
| MDR Report Key | 8659822 |
| Report Source | OTHER |
| Date Received | 2019-05-31 |
| Date of Report | 2019-05-02 |
| Date of Event | 2019-04-23 |
| Date Mfgr Received | 2019-05-02 |
| Date Added to Maude | 2019-05-31 |
| 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 | KRISTIN FORNIERI |
| Manufacturer Street | 36 & 37 APPLE RIDGE ROAD |
| Manufacturer City | DANBURY CT 06810 |
| Manufacturer Country | US |
| Manufacturer Postal | 06810 |
| Manufacturer Phone | 2037318491 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SECURMARK |
| Generic Name | BIOPSY SITE TISSUE MARKER DEVICE |
| Product Code | NEU |
| Date Received | 2019-05-31 |
| Model Number | SMARK-U-SS2 |
| Catalog Number | SMARK-U-SS2 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-31 |