BACKSTOP CLEAR GEL WITH 3R CATHETER 390-900 M0063909000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2012-05-29 for BACKSTOP CLEAR GEL WITH 3R CATHETER 390-900 M0063909000 manufactured by Pluromed Inc..

Event Text Entries

[2745821] Backstop gel is a self-forming polymeric plug with reverse thermosensitive properties. When the temp of the gel increases, its viscosity increases and it forms a plug that is intended for use in the ureter to prevent migration of renal calculi during intracorporeal lithotripsy procedures. The material is water soluble and is removed by irrigating the plug with saline. Report received from a physician via distributor on (b)(4) 2012 regarding an unidentified, pt who underwent ureteroscopy procedure that was performed on (b)(6) 2012. The pt was treated with backstop. The dose, location, and time of residence was not provided. The pt was also treated with levequin immediately postoperatively and discharged that evening. Post procedure, the next day, the pt went to the er with facial swelling and was placed in icu. The physician was concerned it might be an allergic reaction to the backstop material or the levequin that was administered to the pt. F/u info received on 5/4/2012 indicated the physician did not have any further clarification of which of the two suspected materials caused the allergic reaction, levequin was administered immediately post case. There were no signs of allergic reaction following the (b)(6) 2012 procedure. The sales rep also reported that something was given to the pt on (b)(6) 2012 to help with the swelling on but did not know what it was. On (b)(6) 2012, the pt left hosp and his condition was reported to be "fine. "
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3008867907-2012-00001
• MDR Report Key: 2593835
• Report Source: 08
• Date Received: 2012-05-29
• Date of Report: 2012-05-29
• Date of Event: 2012-04-18
• Date Mfgr Received: 2012-04-30
• Date Added to Maude: 2012-08-06
• 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: JOSEPH PELLETIER
• Manufacturer Street: 175 F NEW BOSTON ST
• Manufacturer City: WOBURN MA 01801
• Manufacturer Country: US
• Manufacturer Postal: 01801
• Manufacturer Phone: 7819320574
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BACKSTOP CLEAR GEL WITH 3R CATHETER
• Generic Name: STONE ANTIRETROPULSION DEVICE
• Product Code: ONJ
• Date Received: 2012-05-29
• Model Number: 390-900
• Catalog Number: M0063909000
• Lot Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PLUROMED INC.
• Manufacturer Address: 175 F NEW BOSTON ST WOBURN MA 01801 US 01801

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2012-05-29