MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-07-20 for THE SPANNER TEMPORARY PROSTATIC STENT SPNR-8 manufactured by Abbeymoor Medical Inc..
[1366575]
The physician reported one of his patients developed severe urosepsis requiring hospitalization after spanner removal. The spanner was inserted on (b)(6), the day after receiving transurethral microwave thermotherapy (tumt). The pt wore the device for 2 weeks. After spanner removal a foley catheter had to be placed. Later that same day, the pt called complaining of fever and chills. The physician put him on levaquin right away. The pt was hospitalized for one week. He is being treated for (b)(6) with iv antibiotics for six weeks. The physician has seen the pt twice since being released from the hospital and he is doing much better. Physician stated the pt had high residuals of urine in her bladder prior to the tumt which may have predisposed him to infection and is not sure if the infection was related to the spanner or the tumt.
Patient Sequence No: 1, Text Type: D, B5
[8587905]
The device was not returned for analysis. A review of the dhr was not performed due to the lot number not being provided. Every device lot is verified as sterile before release into inventory. Urinary tract infections are not a significant rate of occurrence.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005249627-2010-00003 |
| MDR Report Key | 1767497 |
| Report Source | 05 |
| Date Received | 2010-07-20 |
| Date of Report | 2010-07-19 |
| Date of Event | 2010-06-02 |
| Date Mfgr Received | 2010-06-28 |
| Date Added to Maude | 2012-03-14 |
| 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 Street | 501 EAST SOO STREET |
| Manufacturer City | PARKERS PRAIRIE MN 56361 |
| Manufacturer Country | US |
| Manufacturer Postal | 56361 |
| Manufacturer Phone | 2183386700 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THE SPANNER TEMPORARY PROSTATIC STENT |
| Generic Name | TEMPORARY PROSTATIC STENT |
| Product Code | NZC |
| Date Received | 2010-07-20 |
| Model Number | SPNR-8 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBEYMOOR MEDICAL INC. |
| Manufacturer Address | 501 EAST SOO STREET PARKERS PRAIRIE MN 56361 US 56361 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2010-07-20 |