MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-08-20 for THE SPANNER TEMPORARY PROSTATIC STENT SPNR-9HA manufactured by Abbeymoor Medical, Inc..
[1590464]
The physician reported a patient with sepsis after spanner stent removal. The patient went to the er after developing violent shaking chills and fever two hours after stent removal. The patient was hospitalized and placed on iv zosyn and levaquin antibiotics. He was hospitalized from monday to sunday (6 days). Patient's catheter was removed during hospitalization. Physician states in an email dated (b)(4) patient is doing fine. Follow up information from the physician states the patient had his spanner placed on (b)(6) 2010 and removed on (b)(6) 2010 (5 1/2 weeks).
Patient Sequence No: 1, Text Type: D, B5
[8779527]
The device was not returned for analysis. A review of the dhr was not performed. Every device lot is verified as sterile before release into inventory. Urinary tract infections are not a significant rate of occurrence. The patient is a diabetic which is a risk factor for developing infections.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005249627-2010-00005 |
| MDR Report Key | 1821643 |
| Report Source | 05 |
| Date Received | 2010-08-20 |
| Date of Report | 2010-08-26 |
| Date of Event | 2010-08-02 |
| Date Mfgr Received | 2010-08-03 |
| Date Added to Maude | 2012-03-12 |
| 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 E 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 | MER |
| Date Received | 2010-08-20 |
| Model Number | SPNR-9HA |
| Lot Number | 240 |
| Device Expiration Date | 2013-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBEYMOOR MEDICAL, INC. |
| Manufacturer Address | 501 E SOO STREET PARKERS PRAIRIE MN 56361 US 56361 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2010-08-20 |