MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-20 for ADVANTAGE FIT SYSTEM M0068502110 manufactured by Boston Scientific.
[100694774]
Boston scientific, advantage fit system, transvaginal mid-urethral sling, trocar punctured through blue sheath of implant. Unable for implant to be inserted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075379 |
| MDR Report Key | 7285634 |
| Date Received | 2018-02-20 |
| Date of Report | 2018-02-16 |
| Date of Event | 2018-02-16 |
| Date Added to Maude | 2018-02-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ADVANTAGE FIT SYSTEM |
| Generic Name | TRANSVAGINAL MID-URETERAL SLING |
| Product Code | PAI |
| Date Received | 2018-02-20 |
| Model Number | M0068502110 |
| Catalog Number | M0068502110 |
| Lot Number | 21182807 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-20 |