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

Model Number	40014
Medical Device Problem Codes	Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer's investigation showed that the catheter had been cut in the packaging welding and cutting process.A corrective and preventive action (capa) plan is established and soon finalized.The capa includes for instance 100% visual control of packages in production before release, updating of instructions for quality control, training of staff and new alignment and storage instructions for semi-manufactured catheters.The probability for detection of this type of deficiency is high since the catheters are visually inspected during production and this incident is therefore seen as an isolated case.Due to the corrective and preventive actions taken and ongoing in the capa, the probability for re-occurrence is considered to be low.
Event or Problem Description
The patient experienced pain during intermittent urinary catheterization (cic).The catheter was carefully removed, and the patient saw that the catheter tip was cut, with a sharp ending.No bleeding occurred and no medical treatment was required.The pain lasted for three days, and then the patient had recovered.No medical complication occured.This event occurred in (b)(6).

• Brand Name: LOFRIC CLASSIC
• Common Device Name: LOFRIC
• Manufacturer (Section D): WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB; aminogatan 1; p.o. box 14; moelndal, SE-43 121; SW SE-43121
• MDR Report Key: 8662387
• Report Number: 3009632672-2019-00005
• Device Sequence Number: 13998922
• Product Code: EZD
• UDI-Device Identifier: 07392532131844
• UDI-Public: 07392532131844
• Combination Product (Y/N): N
• PMA/510(K) Number: K113424
• 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): 05/07/2019

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 Expiration Date: 01/09/2022
• Device Model Number: 40014
• Device Catalogue Number: 40014
• Device Lot Number: 18193
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 06/03/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other