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.
[1068130]
It was reported to boston scientific corporation on october 17, 2005 that an enteryx procedure kit was implanted in a female patient approx two months prior as a repeat procedure (original treatment date was early 2005) (patient weight unknown). A total of 5 injections were performed, delivering a total of 6. 9 cc's of enteryx solution. It was reported that all of these injections were intramuscular and none were submucosal. According to the complainant, the patient experienced an onset of odynophagia and dysphagia of moderate intensity approx eight months later after the procedure. The patient reported weight loss of approximately 5 to 10 pounds that month. No interventions were reported. In the following month, the dysphagia and odynophagia were reported to decrease to mild intensity and the weight loss to be resolved.
Patient Sequence No: 1, Text Type: D, B5
[8252115]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-01938 |
| MDR Report Key | 1333207 |
| Report Source | 00,02,05,07 |
| Date Received | 2009-03-05 |
| Date of Report | 2005-10-17 |
| Date of Event | 2005-08-24 |
| Date Mfgr Received | 2005-10-17 |
| Device Manufacturer Date | 2005-01-10 |
| 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 | 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 | 41228 |
| Device Expiration Date | 2006-12-31 |
| Operator | PHYSICIAN |
| 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 |