MAUDE Adverse Event Report: WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB LOFRIC HYDRO-KIT; CATHETER, URETHRAL

Model Number	42312
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Pain (1994); Urinary Tract Infection (2120); Foreign Body In Patient (2687)
Date of Event	07/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has investigated the batch records and the returned products from the actual lot, and performed a through investigation by means of scrutinizing all steps in the manufacturing process.The manufacturer has concluded that this type of catheter damage could not occur in the manufacturing process.The manufacturer has reviewed historical incident data for past 10 yrs and is not aware of any other complaints for the lofric hydro-kit family, describing a similar event.At this point, the manufacturer therefore consider this to be an exceptional, isolated case, and cannot find any possible explanation for the defect catheters.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Event or Problem Description
The patient experienced problems while performing intermittent catheterization.The patient reports that she has experienced pain, high temperature and urinary tract infections.The patient went to hospital and a cytoscopy was performed where broken urinary catheter tips were discovered and subsequently removed from the bladder.The patient was discharged from the hospital the same day, given a low dose of antibiotics for prophylaxis to use for 5-6 months and also reports taking pain medication after the cytoscopy.The patient reports that she since the discharge she is using foley catheters, and according to the doctor´s advice she can perform intermittent catheterization or use the foley catheter as an indwelling catheter.

• Brand Name: LOFRIC HYDRO-KIT
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB; aminogatan 1; p.o. box 14; mölndal, västra götalands län SE-43 121; SW SE-43121
• MDR Report Key: 10436437
• Report Number: 3009632672-2020-00009
• Device Sequence Number: 3974657
• Product Code: EZD
• UDI-Device Identifier: 07392532142673
• UDI-Public: 07392532142673
• Combination Product (Y/N): N
• PMA/510(K) Number: K122078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/21/2020

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: Lay User/Patient
• Device Expiration Date: 08/28/2023
• Device Model Number: 42312
• Device Catalogue Number: 42312
• Device Lot Number: 449548
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 45 YR