MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,07 report with the FDA on 2009-02-25 for ENTERYX PROCEDURE KIT M00572600 7260 manufactured by Boston Scientific Corporation- Marlborough.
[20919783]
Note: date of event is unknown. It was reported to boston scientific corporation in 2007 that an enteryx procedure, kit was implanted (female patient; weight unknown). According to the complainant, the patient's son learned about the product recall on the internet. The patient said "she is having a continuous severe pain, feels like having a heart attack. On all her x-rays since the procedure, an object is highlighted like a dense piece of object always floating around, and it is always in a different place all the time and there is concern that it can go to a bad place in the body and cause serious harm. She had procedure done sometime in 2005. Always gets infection around the esophagus in front of the heart. "
Patient Sequence No: 1, Text Type: D, B5
[21194832]
Other (pain with swallowing). The complainant was unable to provide the suspect device lot number; therefore, the device manufacture date and expiration date are unknown. Month and day of implant date is unknown, year is 2005. 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 | 3005099803-2008-02519 |
| MDR Report Key | 1324809 |
| Report Source | 04,05,07 |
| Date Received | 2009-02-25 |
| Date of Report | 2007-04-23 |
| Date Mfgr Received | 2007-04-23 |
| Date Added to Maude | 2009-02-25 |
| 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 | 2009-02-25 |
| 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 | 2009-02-25 |