MAUDE Adverse Event Report: Lake Region Medical ZIPwire¿; Urological Catheter and accessories

Model Number	M0066802050
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/28/2026
Type of Reportable Event	Serious Injury

• Brand Name: ZIPwire¿
• Common Device Name: Urological Catheter and accessories
• Manufacturer (Section D): Lake Region Medical; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): Venusa de Mexico S. de R.L. de C.V.; calle hertz 1525; parque industrial a j bermudez; ciudad juarez, chihuahua 32470 ; MX 32470
• Manufacturer Contact: victoria foss ; 340 lake hazeltine drive; chaska, MN 55318 ; +1(952)641-8506
• MDR Report Key: 50829082
• Report Number: 9680001-2026-00024
• Device Sequence Number: 8653321
• Product Code: EYA
• UDI-Device Identifier: 00816349011757
• UDI-Public: (01)00816349011757(17)290129(10)JZ10465775
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: Health Professional
• Device Model Number: M0066802050
• Device Catalogue Number: M0066802050
• Device Lot Number: JZ10465775
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/18/2026
• 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