MAUDE Adverse Event Report: WELLSPECT HEALTHCARE, A DIVISON OF DENTSPLY IH AB LOFRIC SENSE; LOFRIC SENSE NELATON 15CM, CH14

Model Number	41614
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the complaint description: "patient has been bleeding for four weeks (3-4 times a week).According to urologist, she has "abrasions" in the bladder." due to usage of suprapubic catheter.Sample was examined and no visual defects could be found on the catheter.Test of slipperiness could not be carried out because the catheter had already been wetted.Batch documentation has been reviewed and showed that products were produced according to specifications.Ref lot name: 4161416 430058 lofric sense nelaton 15cm ch14 de.Production data: the catheters have been produced in the coating process between (b)(6) 2019 11:53 and 2019-01-09 21:52.Lofric surface assessment has been approved by process operators.The catheters have been punched in sva 1, 2 and 4 between (b)(6) 2019 21:19 and (b)(6) 2019 22:20.Manufacturing date: 2019-01-11 00:43.Expiry date: 2021-01-28.No deviations or earlier complaints registered for this lot.
Event or Problem Description
This case was reported in (b)(6).The complaint was submitted by the customer herself.She had a suprapubic catheter in the past.Her doctor told her on her visit that she had "abrasions" in the bladder and she may need to get another suprapubic catheter to help heal the abrasions in the bladder.The urologist advised her to contact the manufacturer sales representative to check if the catheterization with lofric sense has been done correctly.The general condition of the patient is good.The customer has not mentioned any uti or other medical treatments or hospitalization.She intends to go to the urologist again within the next 14 days.

• Brand Name: LOFRIC SENSE
• Common Device Name: LOFRIC SENSE NELATON 15CM, CH14
• Manufacturer (Section D): WELLSPECT HEALTHCARE, A DIVISON OF DENTSPLY IH AB; aminogatan 1, p.o.box 14; molndal, SE-43 1 21; SW SE-431 21
• MDR Report Key: 8666416
• Report Number: 3009632672-2019-00006
• Device Sequence Number: 16708669
• Product Code: EZD
• UDI-Device Identifier: 07392532086489
• UDI-Public: 07392532086489
• Combination Product (Y/N): N
• PMA/510(K) Number: K123751
• 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): 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/28/2021
• Device Model Number: 41614
• Device Catalogue Number: 41614
• Device Lot Number: 430058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 06/04/2019
• 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: 57 YR
• Patient Weight: 65