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

Model Number	40012
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	01/01/2006
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was available to be returned.Without the benefit of examination and testing wellspect healthcare is precluded from commentings on the condition of the device or the cause of the occurrence.Should devices or additional information be received, a follow up report will be filed.
Event or Problem Description
Complaint information provided by user located in (b)(6) (reporter) in writing and via oral follow up communication: the reporter underwent a bladder augmentation (augmentation cystoplasty) in yr2000 and has used the manufacturer's catheters for intermittent urinary catheterization (ic) since then, 5-6 times daily.He claims having experienced problems, when performing the ic-procedure, with the catheters' coating and repeatedly during the last 14 yrs but has not raised any complaint earlier.The catheter coating is claimed to sometimes be rough or sharp.This is said to having caused considerable discomfort, causing bleedings that in turn is has led to frequent infections with repeated antibiotic treatments.The patients has visited several urologists and gps, but the healthcare professionals has not understood why he has had these infections.The reporter has however recently concluded it is caused by the catheters which is why he was now reporting the matter.The batch of lofric catheters being used at the time of raising the complaints is said not to cause any problems like those described.He was encouraged to send the manufacturer lot numbers and samples of previous batches, if available, for investigation but nothing has been received so far and it is not considered likely to come.The reporter does not wish to change to another catheter product.Repeated and frequency attempts for contacting his gp for more information has been unsuccessful.

• Brand Name: LOFRIC
• Common Device Name: LOFRIC CLASSIC
• Manufacturer (Section D): WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB; aminogatan 1, p.o. box 14,; SE-43 121; SW SE-43121
• MDR Report Key: 9599755
• Report Number: 3009632672-2020-00011
• Device Sequence Number: 13601997
• Product Code: EZD
• UDI-Device Identifier: 07392532131851
• UDI-Public: 07392532131851
• 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): 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 40012
• Device Catalogue Number: 40012
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 01/17/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other