MAUDE Adverse Event Report: WELLSPECT HEALTHCARE LOFRIC HYDRO-KIT; CATHETER, STRAIGH

Model Number	42012
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	03/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient reported that he is affected by pain and burning after each catheterization with all urinary catheters from all brands.He reported that he chooses the lofric hydro-kit catheters from wellspect healthcare because he is least affected by catheters from wellspect healthcare.The patient has a known allergy to plastic of transparent dressings, sorbitan sesquiolate, sorbitan oleate, linalool and sodium metabisulfites.Sorbitan sesquiolate, sorbitan oleate, linalool and sodium metabisulfites are neither intentionally added to, nor known to be components of lofric hydro-kit.The product has undergone biological safety evaluation in accordance with iso 10993, including both chemical and biological testing.These specific substances were not detected in chemical characterization analyses, and biological testing showed no evidence of sensitization reactions from lofric hydro-kit.Therefore, it cannot be concluded that the allergic reaction was caused by using lofric hydro-kit.Lofric hydro-kit is not a dressing but consists of plastic.If the plastic in the product is the cause of the allergic reaction is unknown.The cause of this incident has not been possible to establish.Should additional facts prompt us to alter or supplement any information of conclusions contained in this report, a follow-up report will be submitted.
Event or Problem Description
The adverse event occurred outside us, in (b)(6).A male patient has been using, sterile, single-use intermittent urinary catheters, lofric hydro-kit nelaton (40cm, ch12).On (b)(6) 2025, the patient contacted the manufacturer representative and reported that he gets pain and burning on the penis in connection with the use of the catheters.The patient suspected an allergic reaction.The patient did seek medical care on (b)(6), and tests made on the patient revealed he has allergy to sorbitan sesquiolate, sorbitan oleate, linalool and sodium metabisulfites.The patient was treated with an injection of sphincter toxin for relaxing the sphincter.In addition to this the patient also has got a known allergy to plastic of transparent dressings.The patient also reported that he is affected by pain and burning after each catheterization with all urinary catheters from all brands.The patient reported that he chooses catheters from wellspect healthcare because he is least affected by those catheters.The patient has been using catheters for 6 months to 1 year.

• Brand Name: LOFRIC HYDRO-KIT
• Common Device Name: CATHETER, STRAIGH
• Manufacturer (Section D): WELLSPECT HEALTHCARE; aminogatan 1; p.o. box 14; mölndal, SE-43 121; SW SE-43 121
• Manufacturer Contact: anja bengtzelius ; aminogatan 1; p.o. box 14; mölndal, SE-43- 121 ; SW SE-43 121
• MDR Report Key: 21686064
• Report Number: 3009632672-2025-00010
• Device Sequence Number: 8773987
• Product Code: EZD
• UDI-Device Identifier: 07333387042817
• UDI-Public: 07333387042817
• Combination Product (Y/N): N
• PMA/510(K) Number: K122078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/25/2025

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 Model Number: 42012
• Device Catalogue Number: 42012703
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male