MAUDE Adverse Event Report: WELLSPECT HEALTHCARE SURITY FEMALE EXTERNAL CATHETER

Model Number	38011
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	03/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer asked the user for the lot number, but it was not provided.Due to that batch documentation could not be reviewed.Based on the device's biocompatibility profile, the likelihood of an allergic reaction is low; however, a causal relationship cannot be definitively ruled out.A determination of whether the event represents an allergic reaction, skin irritation, or an unknown etiology could not be made.As reported, use of an over-the-counter antifungal (yeast) cream contributed to the resolution of the symptoms.
Event or Problem Description
A female user reported on the manufacturer´s facebook ad that "i have an.Allergic reaction to the catheter." when the manufacturer contacted the user and spoke with her, she further reported that she had placed the device on the outer labia and developed an itchy rash that covered her perineum.She did not seek medical attention.She used some over the counter "yeast infection cream" and the rash has since resolved.

• Brand Name: SURITY FEMALE EXTERNAL CATHETER
• Common Device Name: SURITY FEMALE EXTERNAL CATHETER
• 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: 24909273
• Report Number: 3009632672-2026-00013
• Device Sequence Number: 15902668
• Product Code: NZU
• UDI-Device Identifier: 07333387056630
• UDI-Public: 07333387056630
• Combination Product (Y/N): N
• PMA/510(K) Number: N/A, EXEMPT
• 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): 04/16/2026

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: 38011
• Device Catalogue Number: 3801140
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/17/2026
• 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: Female