ADVANTAGE FIT ULTRA SYSTEM
Report
- Report Number
- 2124215-2025-75900
- Event Type
- Malfunction
- Date Received
- October 28, 2025
- Date of Event
- October 2, 2025
- Report Date
- December 17, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OTN
- UDI-DI
- 00191506007669
- PMA / PMN Number
- K211223
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK G4: THE COMPLETE PREMARKET/510(K) #: K211223, K231549. BLOCK H6: DEVICE CODE A020503 CAPTURES THE REPORTABLE EVENT OF SEAL COMPROMISED.
BLOCK H11: UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS ADVANTAGE FIT DEVICE UNDERWENT A THOROUGH ANALYSIS. VISUAL INSPECTION OF THE MESH DID NOT REVEAL ANY DAMAGES OR DEFECTS. ADDITIONALLY, THE MESH LOOKED UNUSED, AND A CUT OF THE PRODUCT INFORMATION WAS RETURNED; HOWEVER, THE CLAIMED DAMAGED BOX AND DAMAGED STERILE POUCH WERE NOT RETURNED. BASED ON THE INFORMATION AVAILABLE AND ANALYSIS RESULTS, THE REPORTED ALLEGATIONS OF THE PACKAGING SEAL COMPROMISED AND INCOMPLETE SEAL COULD NOT BE CONFIRMED THROUGH PRODUCT ANALYSIS SINCE THE PACKAGING WAS NOT RECEIVED AND THE DEVICE WAS RECEIVED WITH NO DEFECTS. A CONCLUSION CODE OF CAUSE NOT ESTABLISHED WAS ASSIGNED TO THIS INVESTIGATION AS THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED EVENT. BLOCK G4: THE COMPLETE PREMARKET / 510(K) #: K211223, K231549 BLOCK H6: DEVICE CODE A020503 CAPTURES THE REPORTABLE EVENT OF SEAL COMPROMISED.
IT WAS REPORTED THAT DURING PREPARATION, IT WAS OBSERVED THAT THE DEVICE BOX WAS SLIGHTLY DAMAGED. UPON OPENING, THE STERILE PACKAGE WAS FOUND TO BE PARTIALLY UNSEALED, AND THE DEVICE ITSELF APPEARED SLIGHTLY DENTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.
IT WAS REPORTED THAT DURING PREPARATION, IT WAS OBSERVED THAT THE DEVICE BOX WAS SLIGHTLY DAMAGED. UPON OPENING, THE STERILE PACKAGE WAS FOUND TO BE PARTIALLY UNSEALED, AND THE DEVICE ITSELF APPEARED SLIGHTLY DENTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 255472 | ADVANTAGE FIT ULTRA SYSTEM | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RET | OTN | BOSTON SCIENTIFIC CORPORATION | M0068502160 | 0036731699 | 00191506007669 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female |