MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-01-08 for AFFIRM PRONE BIOPSY SYSTEM, 3D ASY-10430 manufactured by Hologic, Inc.
[132507489]
As of today, the investigation for this issue is in progress. A follow-up will be filed as needed.
Patient Sequence No: 1, Text Type: N, H10
[132507490]
It was reported that when using the system drapes blood continues to get under the compression paddle. "we have blood that we are not able to clean that is around the white label on the paddle. " replacement paddles were sent to the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220984-2019-00004 |
| MDR Report Key | 8229374 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-01-08 |
| Date of Report | 2018-12-10 |
| Date of Event | 2018-12-06 |
| Date Mfgr Received | 2019-01-22 |
| Date Added to Maude | 2019-01-08 |
| 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 | 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 | AFFIRM PRONE BIOPSY SYSTEM, 3D |
| Generic Name | BREAST BIOPSY SYSTEM |
| Product Code | IZH |
| Date Received | 2019-01-08 |
| Model Number | ASY-10430 |
| Catalog Number | ASY-10430 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | 36 & 37 APPLE RIDGE ROAD DANBURY CT 06810 US 06810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-08 |