MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2004-06-25 for ADVANTAGE A/T KIT UNK manufactured by Boston Scientific.
[19145849]
It was reported that a therapeutic advantage sling was placed in 2004. Subsequently the pt presented with a bladder abscess after the mesh eroded into the bladder. Hospitalization and intervention were required. The device remained implanted as of ten days later. No follow up was possible since the physician prefers to remain unidentified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000043-2004-00026 |
| MDR Report Key | 531469 |
| Report Source | 04,05 |
| Date Received | 2004-06-25 |
| Date of Report | 2004-05-26 |
| Date Mfgr Received | 2004-05-26 |
| Date Added to Maude | 2004-06-29 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | NANCY CUTINO |
| Manufacturer Street | ONE BOSTON SCIENTIFIC PLACE |
| Manufacturer City | NATICK MA 017601537 |
| Manufacturer Country | US |
| Manufacturer Postal | 017601537 |
| Manufacturer Phone | 5086525066 |
| Manufacturer G1 | BOSTON SCIENTIFIC |
| Manufacturer Street | 780 BROOKSIDE DRIVE |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVANTAGE A/T KIT |
| Generic Name | SURGICAL SLING |
| Product Code | FHK |
| Date Received | 2004-06-25 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 520716 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | 780 BROOKSIDE DR. SPENCER IN 47460 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2004-06-25 |