MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,05,07 report with the FDA on 2012-07-13 for PROLIEVE THERMODILITATION SYSTEM M0068808022 880-802 manufactured by Boston Scientific - Marlborough.
[2818594]
It was reported to boston scientific corporation that a prolieve thermodilatation system kit was used during a successful procedure on (b)(6), 2009 as a part of a (b)(4) to treat benign prostatic hyperplasia (bph). There were no reported product issues during the procedure. During a postoperative visit on (b)(6), 2011, the subject developed a urethral stricture that was treated surgically. On (b)(6), 2012, the event was considered resolved without residual effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2012-02643 |
| MDR Report Key | 2654731 |
| Report Source | 02,05,07 |
| Date Received | 2012-07-13 |
| Date of Report | 2012-06-20 |
| Date of Event | 2011-12-22 |
| Date Mfgr Received | 2012-06-20 |
| Device Manufacturer Date | 2008-12-11 |
| Date Added to Maude | 2012-07-13 |
| 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 | EMP. CHARLES MONTGOMERY |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Manufacturer G1 | ACCELLENT ENDOSCOPY JUAREZ |
| Manufacturer Street | 31C BUTTERFIELD TRAIL |
| Manufacturer City | EL PASO TX 79906 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 79906 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROLIEVE THERMODILITATION SYSTEM |
| Generic Name | SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY |
| Product Code | MEQ |
| Date Received | 2012-07-13 |
| Model Number | M0068808022 |
| Catalog Number | 880-802 |
| Lot Number | 0000608169 |
| Device Expiration Date | 2010-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-07-13 |