MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,07 report with the FDA on 2009-10-28 for ENTERYX PROCEDURE KIT UNK manufactured by Boston Scientific Corporation.
[1247547]
Note: the procedure date and event date are unk. It was reported to boston scientific corp on sept 28, 2009 that a male pt had received enteryx treatment for gastroesophageal reflux disease. According to the complainant, the pt developed an ulcer or lesion at the injection site (esophagus, lower esophageal sphincter). The treatment for the ulcer or lesion, the pt's current condition and prognosis, are unk. Numerous attempts to obtain additional info have been unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
[8340577]
The complainant was unable to provide the device model, catalog # or lot #; therefore, the manufacture and exp dates are unk. The device has not been returned, and as this device is an implantable material, it is unlikely to be returned. The cause of the reported ulcer or lesion could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2009-05041 |
| MDR Report Key | 1518626 |
| Report Source | 00,01,05,07 |
| Date Received | 2009-10-28 |
| Date of Report | 2009-09-28 |
| Date Mfgr Received | 2009-09-28 |
| Date Added to Maude | 2009-11-03 |
| 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 | 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 | 2009-10-28 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2009-10-28 |