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 2018-12-13 for AFFIRM PRONE BIOPSY SYSTEM ASY-10430 manufactured by Hologic, Inc.
[130343081]
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
[130343082]
It was reported that during a biopsy "with bleeding of any amount, the blood is getting past adhesive side of drape and table/stage/compression paddle is bloody. " no injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220984-2018-00181 |
| MDR Report Key | 8161566 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-12-13 |
| Date of Report | 2018-11-16 |
| Date of Event | 2018-11-05 |
| Date Mfgr Received | 2019-01-22 |
| Date Added to Maude | 2018-12-13 |
| 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 |
| Generic Name | BREAST BIOPSY SYSTEM |
| Product Code | IZH |
| Date Received | 2018-12-13 |
| Model Number | ASY-10430 |
| Catalog Number | ASY-10430 |
| Lot Number | M180917 |
| 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 | 2018-12-13 |