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 2012-03-01 for PROLIEVE THERMODILITATION SYSTEM M0068808022 880-802 manufactured by Boston Scientific - Marlborough.
[2524571]
It was reported to boston scientific corporation that a prolieve thermodilatation system kit was used during a successful procedure on (b)(6), 2007 as a part of a (b)(4) to treat benign prostatic hyperplasia (bph). During a postoperative visit on (b)(6), 2011, the subject developed prostatitis, which was treated with medication. On (b)(6) 2011, the event was reported as resolved without residual effects. Follow up with the complainant revealed levaquin 500 mg was given for the prostatitis.
Patient Sequence No: 1, Text Type: D, B5
[2753150]
It was reported to boston scientific corporation that a prolieve thermodilatation system kit was used during a successful procedure on (b)(6), 2007 as a part of a (b)(4) to treat benign prostatic hyperplasia (bph). During a postoperative visit on (b)(6), 2011, the subject developed prostatitis, which was treated with medication. On (b)(6), 2011, the event was reported as resolved without residual effects. Follow up with the complainant revealed levaquin 500 mg was given for the prostatitis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2012-00617 |
| MDR Report Key | 2474659 |
| Report Source | 02,05,07 |
| Date Received | 2012-03-01 |
| Date of Report | 2012-02-10 |
| Date of Event | 2011-08-25 |
| Date Mfgr Received | 2012-04-17 |
| Device Manufacturer Date | 2006-10-31 |
| Date Added to Maude | 2012-03-01 |
| 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 |
| 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 | 2012-03-01 |
| Model Number | M0068808022 |
| Catalog Number | 880-802 |
| Lot Number | 0000602499 |
| Device Expiration Date | 2008-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2012-03-01 |