MAUDE Adverse Event Report: WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB LOFRIC ORIGO (40 CM NELATON FR12); CATHETER, STRAIGHT

Model Number	44312
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not available to be returned.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 additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Event or Problem Description
According to the complaint reporter the user was instructed on the (b)(6) on how to perform intermittent catheterization (ic).The user had then self catheterized as usual.In the morning of (b)(6) 2020 and during insertion in the bladder, as user described, it started to bleed "relatively heavily" with blood clots coming out a bit later.

• Brand Name: LOFRIC ORIGO (40 CM NELATON FR12)
• Common Device Name: CATHETER, STRAIGHT
• Manufacturer (Section D): WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB; aminogatan 1; p.o. box 14; mölndal, västra götalands län SE-43 121; SW SE-43121
• MDR Report Key: 10117663
• Report Number: 3009632672-2020-00006
• Device Sequence Number: 2625428
• Product Code: EZD
• UDI-Device Identifier: 07392532158292
• UDI-Public: 07392532158292
• Combination Product (Y/N): N
• PMA/510(K) Number: K122078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2020

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: Lay User/Patient
• Device Expiration Date: 02/27/2022
• Device Model Number: 44312
• Device Catalogue Number: 44312
• Device Lot Number: 450039
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR