MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04,05,07 report with the FDA on 2008-02-13 for ENTERYX PROCEDURE KIT M00572500 7250 manufactured by Boston Scientific Corporation.
[3196020]
It was reported to boston scientific corp on (b)(6) 2008 that an enteryx procedure kit was used to treat gastroesophageal reflux disease (gerd) in a (b)(6), female pt on (b)(6) 2005. According to the complainant, "the physician told (the pt) that her (lower esophageal) sphincter does not work. This has made her asthma worse and she has difficulty swallowing. She had her esophagus dilated on ((b)(6) 2008; device and mfr unk). She has lost 25 pounds and everything she eats causes pain. "
Patient Sequence No: 1, Text Type: D, B5
[10551123]
(b)(4). These codes were selected by the mfr based on info obtained from the user facility. The lot number is unk; therefore, the manufacture date cannot be determined. The device remains implanted in the pt; therefore, a failure analysis is not available and the relationship between this device and the cause of this event is undetermined. The lot number of the suspect device is unk. A customer shipment history review revealed two lots which were shipped to the customer (lots 40112 and 40611). The device history record (dhr) for each lot was reviewed; no anomalies were noted. Note: this product was removed from the global market in september 2005. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-00149 |
| MDR Report Key | 2997973 |
| Report Source | 00,04,05,07 |
| Date Received | 2008-02-13 |
| Date of Report | 2008-01-17 |
| Date Mfgr Received | 2008-01-17 |
| Date Added to Maude | 2013-03-13 |
| 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 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 46 BARBOUR POND RD |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07470 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENTERYX PROCEDURE KIT |
| Product Code | LMN |
| Date Received | 2008-02-13 |
| Model Number | M00572500 |
| Catalog Number | 7250 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | WAYNE NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-02-13 |