MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-14 for ATEC AND EVIVA BREAST BIOPSY KIT ILS 0914-12 manufactured by Hologic, Inc..
[111710334]
The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed. If the device is returned and evaluation completed, a supplemental medwatch will be filed device history record (dhr) review was conducted for the reported identification number. The lot was released meeting all qa specifications. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[111710335]
It was reported a physician performed a breast biopsy procedure on (b)(6) 2018 and the tip of the plastic introducer remained inside the patient. The physician removed the piece and completed the procedure. There was no patient injury. The patient was discharged home.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2018-00133 |
| MDR Report Key | 7602845 |
| Date Received | 2018-06-14 |
| Date of Report | 2018-06-01 |
| Date of Event | 2018-06-01 |
| Date Mfgr Received | 2018-07-09 |
| Date Added to Maude | 2018-06-14 |
| 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 | MS. SIDRA PIRACHA |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638884 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ATEC AND EVIVA BREAST BIOPSY KIT |
| Generic Name | BREAST BIOPSY / LOCALIZATION TRAY |
| Product Code | PXP |
| Date Received | 2018-06-14 |
| Model Number | ILS 0914-12 |
| Lot Number | 17F09R |
| Device Expiration Date | 2019-06-09 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| 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 | 2018-06-14 |