MAUDE Adverse Event Report: MED-NAP CASTILE SOAP TOWELETTES; DEGREASER, SKIN, SURGICAL

Lot Number MN13423

Device Problem Use of Device Problem (1670)

Patient Problems Diarrhea (1811); Hematuria (2558); Dysuria (2684); Thrombosis/Thrombus (4440)

Event Date 06/28/2023

Event Type  Injury  

Event Description

The patient went to quest to drop off a urine specimen and used a castile wipe (med-nap) to clean the penis.When the patient began to urinate, they had dysuria and gross hematuria (which were not present prior to that time).The hematuria continued for several hours which included blood clots at the tip of the penis.The patient also had an episode of diarrhea with loose stool (no nausea or cramps) with the hematuria.The urine cleared after a few hours.However, there was another episode of diarrhea with recurrent gross hematuria.The symptoms fully resolved in several hours.A subsequent urinalysis was unremarkable except for occult blood on the dipstick test but not on microscopic exam.A very strange occurrence which i thought should be reported.

• Brand Name: CASTILE SOAP TOWELETTES
• Type of Device: DEGREASER, SKIN, SURGICAL
• Manufacturer (Section D): MED-NAP
• MDR Report Key: 17254551
• MDR Text Key: 318463622
• Report Number: MW5119100
• Device Sequence Number: 1
• Product Code: KOY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2023

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
• Device Lot Number: MN13423
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/03/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White