MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2009-04-20 for ENTERYX PROCEDURE KIT UNK manufactured by Boston Scientific Corporation.
[1202187]
Initial procedure and event dates are unk. It was reported to boston scientific corporation that an enteryx procedure kit was used during an enteryx procedure. According to the patient, an enteryx implant procedure was performed in 2005 by dr at the hospital. The patient indicated he has had problems ever since the implant procedure and needs to have surgery to correct the problem. He believes, he needs to have the polymer removed as it has migrated and his esophagus is off to one side. Attempted follow-up was unsuccessful. No additional details are available. Should additional relevant details become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
[8144405]
The complainant was unable to provide the device model, catalog and lot numbers. Therefore, device manufacturer and expiration dates are unk. Upn number unk, therefore, both recall numbers have been identified. The device is not available for investigation. Therefore, we are unable to determine the cause for this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2009-01912 |
| MDR Report Key | 1367432 |
| Report Source | 00 |
| Date Received | 2009-04-20 |
| Date of Report | 2009-03-25 |
| Date Mfgr Received | 2009-03-25 |
| Date Added to Maude | 2009-04-27 |
| 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 | CHARLES MONTGOMERY |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086836132 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01752 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0040-6 & Z-0041-6 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENTERYX PROCEDURE KIT |
| Product Code | LMN |
| Date Received | 2009-04-20 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-04-20 |