MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,05,07 report with the FDA on 2009-03-03 for ENTERYX PROCEDURE KIT M00572600 7260 manufactured by Boston Scientific Corporation- Marlborough.
[1052571]
It was reported to boston scientific corporation in 2005 that an enteryx device was implanted (patient information is unk). It was reported that during the procedure there was "excessive resistance. " it was also noted that the patient came in for a "24 month post retreatment", in 2007 and reported an "ache or pain in stomach or belly increased. "
Patient Sequence No: 1, Text Type: D, B5
[1126290]
Note: this report is a supplement to manufacturer report #3005099803-2008-6335.
Patient Sequence No: 1, Text Type: D, B5
[8185700]
Clinical study. The product remains implanted in the patient; therefore, a device evaluation cannot be performed. Note: the product has been removed from the global market in september 2005. Boston scientific corporation no longer produces the reported product.
Patient Sequence No: 1, Text Type: N, H10
[8396087]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-06335 |
| MDR Report Key | 1328018 |
| Report Source | 02,05,07 |
| Date Received | 2009-03-03 |
| Date of Report | 2004-06-30 |
| Date of Event | 2007-09-11 |
| Date Mfgr Received | 2009-03-16 |
| Date Added to Maude | 2009-05-27 |
| 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 | MR. CHARLES MONTGOMERY |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086836132 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0040-06 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENTERYX PROCEDURE KIT |
| Generic Name | LMN |
| Product Code | LMN |
| Date Received | 2009-03-03 |
| Model Number | M00572600 |
| Catalog Number | 7260 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION- MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-03-03 |