MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TRAY,FOLEY,100% SILICONE,16FR,10ML,LF

Catalog Number	DYND11519H
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Burning Sensation (2146)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer on 10/3, the patient was sitting on the toilet and having a bowel movement and he felt a pop inside and the foley came out.
Additional Manufacturer Narrative
According to the customer on 10/3, the patient was sitting on the toilet and having a bowel movement and he felt a pop inside and the foley came out.This time he had a little bit of blood on the end of the foley as he felt there is a small cut inside his urethra.The customer stated a new foley was placed.One blood clot returned and urine output was received.The customer stated the patient verbalized burning.The balloon was popped.The customer stated there was some bleeding after this incident and burning from possible trauma inside when the foley came out.Preventative antibiotics were ordered since there were multiple attempts made in 3 days and also due to new bleeding.A sample is available for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: TRAY,FOLEY,100% SILICONE,16FR,10ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 20577907
• Report Number: 1417592-2024-00928
• Device Sequence Number: 12786153
• Product Code: OHR
• UDI-Device Identifier: 10080196809790
• UDI-Public: 10080196809790
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2024

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 Catalogue Number: DYND11519H
• Device Lot Number: 96924030002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 54 KG