MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-02 for SONABLATE manufactured by Focus Surgery, Inc.
[143877372]
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Patient Sequence No: 1, Text Type: N, H10
[143877374]
The patient had a whole gland ablation in february post op he was very constipated for one week treated with oral medication had diarrhea for few weeks no rectal suppository or enema was used he complained the fourth week post op of regular bowl movement but a teaspoon of clear liquid drainage after the bowl movement cystogram showed small rectal fistula. Patient was referred to usc for repair as conservative s/p drainage did not close the fistula" and again after another follow up the following response was received from the physician: "procedure was done on 17 february i believe his constipation and straining to stool and void could have contributed to the fistula please review case and let me know.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951226-2017-00001 |
| MDR Report Key | 8575024 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-02 |
| Date of Report | 2019-03-13 |
| Date of Event | 2017-02-17 |
| Date Mfgr Received | 2017-09-29 |
| Device Manufacturer Date | 2016-03-25 |
| Date Added to Maude | 2019-05-02 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS REBECCA WOOD |
| Manufacturer Street | 4000 PENDLETON WAY |
| Manufacturer City | INDIANAPOLIS IN 46226 |
| Manufacturer Country | US |
| Manufacturer Postal | 46226 |
| Manufacturer Phone | 3177131064 |
| Manufacturer G1 | FOCUS SURGERY INC |
| Manufacturer Street | 4000 PENDLETON WAY |
| Manufacturer City | INDIANAPOLIS IN 46226 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46226 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SONABLATE |
| Generic Name | HIGH INTENSITY FOCUSED ULTRASOUND DEVICE |
| Product Code | PLP |
| Date Received | 2019-05-02 |
| Model Number | SONABLATE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FOCUS SURGERY, INC |
| Manufacturer Address | 4000 PENDLETON WAY INDIANAPOLIS IN 46226 US 46226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-02 |