MAUDE Adverse Event Report: WELLSPECT HEALTHCARE SURITY FEMALE EXTERNAL CATHETER

Model Number	38011
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	03/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has made 3 attempts to contact the user, but the user does not respond.Since the lot number was not provided by the user, the batch documentation could not be reviewed.The only information the manufacturer has is that the user stated that she ended up in icu with uti.The cause of this adverse event has not been possible to establish.
Event or Problem Description
A female user reported on the manufacturer's facebook ad that "i ended up in icu with a uti!".The manufacturer has made 3 attempts to contact the user, but the user does not respond.The only information the manufacturer has is the message on facebook.

• 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: 24911274
• Report Number: 3009632672-2026-00014
• Device Sequence Number: 15724741
• 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): 04/17/2026

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: 03/24/2026
• 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: Hospitalization
• Patient Sex: Female