MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04,07 report with the FDA on 2007-12-28 for VESICA SLING KIT M0068201000 820-100 manufactured by Boston Scientific Corporation.
[19893500]
Note: boston scientific corporation became aware of the reported event through various legal documents; the events had not been previously reported to bsc. Bsc received a letter from the patient's attorney which reported that in 1998, a patient (age and weight unknown) underwent a bladder neck suspension surgery using the vesica sling system. According to the complainant, in 2006, the patient went to the emergency room complaining of "knots in her abdomen" (treatment unknown). It was reported that approximately in approx two and a half months later, a piece of metal was protruding from where she previously had a lump. One of the metal anchors from the vesica sling system had broken loose and had made its way to the surface of her skin. The nature of the patient outcome is unknown at this time. We are unable to obtain any further information regarding this event or the patient's condition. It is unknown at this time if medical or surgical intervention was required.
Patient Sequence No: 1, Text Type: D, B5
[20097762]
The complainant indicated that the device will not be returned for evaluation since it was implanted; therefore, a failure analysis is not available, and we are not able to determine if the device met specification. It was not possible to identify any potential lots for this product through a ship history record review due to the age of the product. The october 2007 15-month sling fixation complaint trend report, inclusive of all failure modes, was reviewed; no adverse trend was noted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000043-2007-00144 |
| MDR Report Key | 970527 |
| Report Source | 00,04,07 |
| Date Received | 2007-12-28 |
| Date of Report | 2007-03-13 |
| Date of Event | 2006-03-12 |
| Date Mfgr Received | 2007-03-13 |
| Date Added to Maude | 2008-01-03 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NANCY CUTINO |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834066 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| 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 | VESICA SLING KIT |
| Product Code | FHK |
| Date Received | 2007-12-28 |
| Model Number | M0068201000 |
| Catalog Number | 820-100 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 941028 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | SPENCER IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2007-12-28 |