MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. FOLEY CATHETER, 400 SERIES 14 FR; CATHETER, UPPER URINARY TRACT

Model Number	81-080414
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	03/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A distributing facility reported, "the hospital reported an incident involving the patient named above, who underwent surgery on (b)(6) 2026, performed by (b)(6).A foley catheter with a temperature probe was placed in situ pre-surgery, together with all other intra-vascular lines.A patient plate was placed on the patient's lower back.It was reported that once the surgery was completed and the drapes were removed, the operating room staff discovered that the patient had sustained a second[?]degree burn injury during the procedure.The burn injury was identified on the patient's penis and scrotum.The foley catheter remained in situ, and the patient was transferred to the surgical icu, where treatment continued for both the surgical procedure and the burn injuries.The incident was formally reported, and the anaesthetist requested an investigation into the matter.The patient was discharged from surgical icu and transferred to a general ward on (b)(6) 2026." deroyal industries, inc.Has requested return of the device, however, it was stated it was not available for return.A supplier corrective action request (scar) will be issued to the supplier xeridiem.This investigation is not complete at this time.No further information is available at this time.We will provide follow up report when additional information becomes available.
Event or Problem Description
A distributing facility reported, "the hospital reported an incident involving the patient named above, who underwent surgery on (b)(6) 2026, performed by (b)(6).A foley catheter with a temperature probe was placed in situ pre-surgery, together with all other intra-vascular lines.A patient plate was placed on the patient's lower back.It was reported that once the surgery was completed and the drapes were removed, the operating room staff discovered that the patient had sustained a second[?]degree burn injury during the procedure.The burn injury was identified on the patient's penis and scrotum.The foley catheter remained in situ, and the patient was transferred to the surgical icu, where treatment continued for both the surgical procedure and the burn injuries.The incident was formally reported, and the anaesthetist requested an investigation into the matter.The patient was discharged from surgical icu and transferred to a general ward on (b)(6) 2026.".

• Brand Name: FOLEY CATHETER, 400 SERIES 14 FR
• Common Device Name: CATHETER, UPPER URINARY TRACT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 24971932
• Report Number: 2320762-2026-00008
• Device Sequence Number: 10456091
• Product Code: EYC
• UDI-Device Identifier: 00749756045773
• UDI-Public: 00749756045773
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K200757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2026

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: Health Professional
• Device Model Number: 81-080414
• Device Lot Number: 62745374
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown