MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2008-08-14 for EXABLATE 2000 manufactured by Insightec, Ltd..
[894941]
Two weeks post exablate treatment, pt was diagnosed by a urologist of having ulceration in her bladder wall. Pt was hospitalized, in a different hospital, for two days and received hemostatic intravenous, which has stopped the bleeding. Pt was discharged from hospital and keeps taking hemostatic medicine.
Patient Sequence No: 1, Text Type: D, B5
[8107699]
There is no evidence that the ae is device related. We are trying to collect more clinical data in order to have conclusive evaluation. We are planning to issue advisory notice to our customers describing the event. We have decided to report this event out of abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615058-2008-00001 |
| MDR Report Key | 1114176 |
| Report Source | 01,07 |
| Date Received | 2008-08-14 |
| Date of Report | 2008-08-13 |
| Date of Event | 2008-07-29 |
| Date Mfgr Received | 2006-04-30 |
| Date Added to Maude | 2008-08-19 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ORI LUBIN, MGR |
| Manufacturer Street | 5 NAHUM HETH ST. PO BOX 2039 |
| Manufacturer City | TIRAT CARMEL 31290 |
| Manufacturer Country | IS |
| Manufacturer Postal | 31290 |
| Manufacturer Phone | 9724813162 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXABLATE 2000 |
| Generic Name | MRGFUS |
| Product Code | NRZ |
| Date Received | 2008-08-14 |
| Model Number | EXABLATE 2000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1105337 |
| Manufacturer | INSIGHTEC, LTD. |
| Manufacturer Address | 5 NAHUM HETH ST. PO BOX 2059 TIRAT CARMEL IS 39120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2008-08-14 |