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.
[20021093]
It was reported to boston scientific corporation on september 22, 2005 that an enteryx procedure kit was implanted in a male patient (weight unknown) in 2004. Eight injections were performed, delivering a total of 8 cc's intramuscularly and none were submucosal. According to the complainant, on the next day, the patient experienced odynphagia of moderate intensity that lasted until the following month. The patient also experienced shortness of breath on exertion. A chest x-ray was done that month, and was normal. This event resolved four days later. A reoccurance of odynophaiga of mild intensity began in 2005 and the patient has lost ten pounds associated with the odynophagia. The odynophagia resolved as of three months later, but the patient has mild dysphagia with weight loss. In early 2007, follow-up with the patient reported that the weight loss had stabilized.
Patient Sequence No: 1, Text Type: D, B5
[20113331]
Other (pain with swallowing) 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. Product unavailable for analysis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-01935 |
| MDR Report Key | 1333359 |
| Report Source | 00,02,05,07 |
| Date Received | 2009-03-05 |
| Date of Report | 2005-09-22 |
| Date of Event | 2004-09-25 |
| Date Mfgr Received | 2005-09-22 |
| Device Manufacturer Date | 2004-06-24 |
| 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 | 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 | 40611 |
| Device Expiration Date | 2006-10-31 |
| 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 |