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 7260 manufactured by Boston Scientific Corporation- Marlborough.
[1067235]
It was reported to boston scientific corporation on september 15, 2005 that an enteryx procedure kit was implanted in a female patient (weight unknown) approx two months prior. A total of six injections were attempted. One injection was extramural. Five injections were given intramuscularly with a total of 7. 8 cc's, and one of the five was given submucosal/intramuscular with 2. 0 cc's. According to the complainant, the following month the patient reported weight loss of 3 pounds at her three week follow-up visit. Also, the patient reported dysphagia with solid foods beginning approx two months prior to original date. Dysphagia continues with solid foods, based on follow-up with the patient ten days after the original date. In 2006, the patient experienced dysphagia and stricture at the squamocolumnar junction. The patient underwent an esophagogastroduodenoscopy (egd) with dilation and the events were reported as resolved as of three days later.
Patient Sequence No: 1, Text Type: D, B5
[8221108]
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. Other text : product unavailable for analysis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-01936 |
| MDR Report Key | 1333360 |
| Report Source | 00,02,05,07 |
| Date Received | 2009-03-05 |
| Date of Report | 2005-09-15 |
| Date of Event | 2005-08-15 |
| Date Mfgr Received | 2005-09-15 |
| Device Manufacturer Date | 2004-11-16 |
| 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 | 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 | 2009-03-05 |
| Model Number | M00572600 |
| Catalog Number | 7260 |
| Lot Number | 41110 |
| 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 |