MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-07-03 for ENTERYX UNK manufactured by Boston Scientific Corporation.
[890844]
In 2008, boston scientific corporation was informed of a patient (a female) who received an enteryx injection procedure in 2005 (actual date is unknown). The patient experienced dysphagia approximately three to four months post procedure and was prescribed nexium. It was further reported that the patient went to her primary care physician with various symptoms (flu-like symptoms, weight loss, inflammation, mucous on vocal chord) and was sent to a gastroenterologist for additional follow-up. In addition, the patient had undergone several esophageal dilatations; one of the dilatations revealed an esophageal nodule. No further information has been ascertainable regarding the reported event.
Patient Sequence No: 1, Text Type: D, B5
[8070185]
The device remains implanted in the patient; a device evaluation could not be performed. The relationship between the device and the cause of the reported event is undetermined. Additional treating physicians include: two drs; dilatation treatment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-01081 |
| MDR Report Key | 1069925 |
| Report Source | 04 |
| Date Received | 2008-07-03 |
| Date of Report | 2008-06-03 |
| Date Mfgr Received | 2008-06-03 |
| Date Added to Maude | 2008-07-11 |
| 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; Z-0041-06 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENTERYX |
| Product Code | LMN |
| Date Received | 2008-07-03 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1038182 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-07-03 |