MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-09-19 for ENTERYX UNK manufactured by .
[955882]
Note: date of event is unknown. It was reported to boston scientific corporation in 2008 that an enteryx device was used during an unknown procedure. According to the pt, the procedure was performed a while ago and she is concerned with feeling as though she may pass out. She reports that some of her post-procedure complaints are mentioned in the recall notice for the enteryx device. The pt is currently scheduled for gallbladder surgery. No further pt info was provided.
Patient Sequence No: 1, Text Type: D, B5
[8192966]
Boston scientific corporation no longer produces the reported product. The complainant was not able to provide the model number, catalog number or lot number of the suspect device, therefore, the device manufacture date is unknown. 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-04708 |
| MDR Report Key | 1168101 |
| Report Source | 05,07 |
| Date Received | 2008-09-19 |
| Date of Report | 2008-08-21 |
| Date Mfgr Received | 2008-08-21 |
| Date Added to Maude | 2008-09-25 |
| 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 |
| Product Code | LMN |
| Date Received | 2008-09-19 |
| 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 | 1197359 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-09-19 |