MAUDE Adverse Event Report: WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB LOFRIC; LOFRIC CLASSIC

Model Number	40516
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	07/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer still waiting for device to be returned for examination.Additional information will be provided in the next follow up report.Without the benefit of examination and testing, wellspect healthcare is precluded from commenting on the condition of the device or the cause of the occurrence.
Event or Problem Description
According to the reporter, the lofric classic urinary catheter got stuck when the patient tried to remove it and the end came off when he tried to pull it out.The catheter had to be extracted by surgery.
Additional Manufacturer Narrative
No deviations or earlier complaints registered for this lot.Samples: 1 piece of tubing and 15 unopened packages (no faulty catheters in them).Examination of the piece of tubing that was surgically removed shows that the catheter tubing has been cut at the "connector end".There are no glue residues on that end so it is not probable that this is a case of the connector coming loose.If the catheter had been cut in the production line the customer would have noticed that the packaging was damaged and that the catheter has no connector.This indicates that the catheter was cut when outside of the package.No relevant deviations were found in the batch documentation.No root cause could be established.It is however considered reasonable to speculate that the cause of the incident in this case is most likely due to that the user is a beginner of doing clean intermittent catheterization.

• Brand Name: LOFRIC
• Common Device Name: LOFRIC CLASSIC
• Manufacturer (Section D): WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB; aminogatan 1; molndal,
• MDR Report Key: 8938712
• Report Number: 3009632672-2019-00008
• Device Sequence Number: 2520775
• Product Code: EZD
• UDI-Device Identifier: 07392532131721
• UDI-Public: 07392532131721
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K113424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Other
• Remedial Action: Notification,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 40516
• Device Catalogue Number: 40516
• Device Lot Number: 18296
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 09/10/2019
• 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: Required Intervention
• Patient Age: 50 YR