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

Model Number	42514
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No products of the actual batch have been returned to the manufacturer and there is no lot-number information provided.Without the benefit of examining batch documentation or product testing, wellspect healthcare is precluded from commenting on the condition of the device or the root cause of incident occurrence.Should the device or additional information be received, that will change any conclusion regarding the incident, a follow-up report will be filed.
Event or Problem Description
According to the reporter, the patient has experienced allergic reactions (redness, inflammation) when using the urinary catheter lofric hydrokit.The patient has used catheters for around 15 years, the allergic reactions occurred in (b)(6) 2020.The allergic reaction was localized on the genitals, no other part of the body was affected.The patient uses the same wipes and soap products as before the allergic reactions occurred.There were no other medical complications.The doctor prescribed medication, and the patient has recovered.The incident occurred in (b)(6).

• Brand Name: LOFRIC HYDROKIT
• Common Device Name: CATHETER, STRAIGHT
• 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: 9804522
• Report Number: 3009632672-2020-00003
• Device Sequence Number: 3002770
• Product Code: EZD
• UDI-Device Identifier: 07392532148569
• UDI-Public: 07392532148569
• 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: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 42514
• Device Catalogue Number: 42514
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 03/09/2020
• 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