MAUDE Adverse Event Report: TELEFLEX MEDICAL PRIVATE LIMITED RUSCH GOLD 2-W LATEX FOLEY, CYLINDRICAL; CATHETER, UROLOGICAL

Model Number	IPN050424
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "balloon did not deflate, patient had to undergo general anesthesia in order to remove catheter".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The product was received for investigation.Upon visual exam it was found that the product is not sold in the us; therefore, the initial mdr, submitted on 12-sept-2023, should be retracted.Other remarks: n/a.Corrected data: n/a.

• Brand Name: RUSCH GOLD 2-W LATEX FOLEY, CYLINDRICAL
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): TELEFLEX MEDICAL PRIVATE LIMITED; pondicherry
• Manufacturer (Section G): TELEFLEX MEDICAL PRIVATE LIMITED; thirubuvanai village; puducheery; pondicherry 60510 7; IN 605107
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17730707
• Report Number: 8040412-2023-00339
• Device Sequence Number: 12397722
• Product Code: KOD
• UDI-Device Identifier: 14026704303073
• UDI-Public: 14026704303073
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN050424
• Device Catalogue Number: 180605-000120
• Device Lot Number: P22K03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2022
• 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
• Patient Sex: Female