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.
[18836070]
It was reported to boston scientific corporation in 2008 that an enteryx device was implanted in 2005 (patient information is uknown). It was reported that the patient had two small ulcers above the ge jxn, chest pain, burping, esophagus pain, and gas. There were no device malfunctions noted during the tx. The subject was noted to have a hiatal hernia during the tx endoscopic assessment. It is unknown if the ulcers were related to the esophageal pain.
Patient Sequence No: 1, Text Type: D, B5
[19030804]
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 2005. Boston scientific corporation no longer produces the reported product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-06338 |
| MDR Report Key | 1328021 |
| Report Source | 02,05,07 |
| Date Received | 2009-03-03 |
| Date of Report | 2008-06-20 |
| Date of Event | 2005-02-23 |
| Date Mfgr Received | 2008-06-10 |
| Date Added to Maude | 2009-03-03 |
| 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 | MR. KEN HIRAKAWA |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086836264 |
| 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 | CERAMICS, CALCIUM TRIPHOSPHATE/HYDROXYPATITE, NON-LOAD BEARING USES |
| Product Code | LMN |
| Date Received | 2009-03-03 |
| Model Number | M00572600 |
| Catalog Number | 7260 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 |