LOFRIC DILACATH 40618

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-06-14 for LOFRIC DILACATH 40618 manufactured by Wellspect Healthcare.

Event Text Entries

[3554885] The customer thinks the coating is rough and he had a bleeding after catheterization.
Patient Sequence No: 1, Text Type: D, B5

[10746600] This submission is being made after an acquisition and internal audit of wellspect healthcare. Samples returned have been analyzed and no defects or deviations could be found. Based upon the product testing, this complaint could not be confirmed as reported.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 3009632672-2013-00022
• MDR Report Key: 3181413
• Report Source: 05
• Date Received: 2013-06-14
• Date of Report: 2011-09-08
• Date Mfgr Received: 2011-09-08
• Date Added to Maude: 2013-06-24
• 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: 0
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: MARIE SKOGLUND
• Manufacturer Street: AMINOGATAN 1 P.O. BOX 14
• Manufacturer City: MOLNDAL SE-43121
• Manufacturer Country: SW
• Manufacturer Postal: SE-43121
• Manufacturer Phone: 13764000
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LOFRIC DILACATH
• Generic Name: URETHRAL DILATOR, FBX
• Product Code: FBX
• Date Received: 2013-06-14
• Model Number: 40618
• Catalog Number: 40618
• Lot Number: 86793
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: WELLSPECT HEALTHCARE
• Manufacturer Address: AMINOGATAN 1 P.O. BOX 14 MOLNDAL SE-43121 SW SE-43121

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2013-06-14