MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,02,05,07 report with the FDA on 2009-03-05 for ENTERYX PROCEDURE KIT M00572600 manufactured by Boston Scientific Corporation- Marlborough.
[1074711]
Note: this report pertains to two of two procedure kits used during the same procedure. Refer to associated manufacturer report number 3005099803-2008-1918 for details on the other procedure kit. It was reported to boston scientific corporation on august 4, 2005 that an enteryx procedure kit was implanted in a patient approx four months prior (patient age, gender and weight are unknown). Two injections were performed, delivering approximately 4 cc's of enteryx solution. It was reported that both injections were intramuscular and neither were submucosal. According to the complainant, the patient experienced the onset of dysphagia with the worsening of a gastroesophageal stricture the following month. The patient underwent an esophagogastroduodenoscopy (egd) with dilation fifteen days later. The patient has not experienced weight loss. The dysphagia was reported to be resolved the following month.
Patient Sequence No: 1, Text Type: D, B5
[8254817]
The device remains implanted in the patient; therefore, a device evaluation cannot be performed. Note: this product was 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
| Report Number | 3005099803-2008-01818 |
| MDR Report Key | 1333386 |
| Report Source | 00,02,05,07 |
| Date Received | 2009-03-05 |
| Date of Report | 2005-08-04 |
| Date of Event | 2005-04-14 |
| Date Mfgr Received | 2005-08-04 |
| Device Manufacturer Date | 2005-01-24 |
| Date Added to Maude | 2009-03-05 |
| 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 | BOSTON SCIENTIFIC CORPORATION 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 | 2009-03-05 |
| Model Number | M00572600 |
| Lot Number | 41029 |
| Device Expiration Date | 2007-05-31 |
| 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 | 2009-03-05 |