MAUDE Adverse Event Report: WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB LOFRIC CLASSIC; CATHETER STRAIGHT

Model Number	40014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No deviations found in batch documentation.No previous complaints on the lot.Without the benefit of examination and testing, wellspect healthcare is precluded from commenting on the condition of the device or the cause of the occurrence.Should the device or additional information be received, a follow up report will be filed.
Event or Problem Description
According to the reporter, which is the user himself, he felt pain during urinary catheterization and when removing the catheter he experienced bleeding.After removing the catheter, he saw a piece of plastic at the catheter eye (hole).The reporter experienced pain and also occasional bleeding several times when inserting a urinary catheter (up to six times per day), during a period of one week.The reporter did not visit any hospital.

• Brand Name: LOFRIC CLASSIC
• Common Device Name: CATHETER STRAIGHT
• Manufacturer (Section D): WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB; aminogatan 1; p.o. box 14; mölndal, sweden SE-43 121; SW SE-43121
• MDR Report Key: 7497654
• Report Number: 3009632672-2018-00002
• Device Sequence Number: 1124517
• Product Code: EZD
• UDI-Device Identifier: 07392532131844
• UDI-Public: 07392532131844
• Combination Product (Y/N): N
• PMA/510(K) Number: K113424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: 40014
• Device Catalogue Number: 40014
• Device Lot Number: 412201
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 05/09/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other