MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TTL1LYR 100%SILI UM MF 16FR SAFES

Catalog Number URO170816SQ

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2022

Event Type  Injury  

Event Description

It was reported by the facility that during a procedure the patient's foley catheter dislodged from the patient requiring a cystoscopy to remove the retained balloon.

Manufacturer Narrative

It was reported by the facility that during a procedure the patient's foley catheter dislodged from the patient requiring cystoscopy to remove retained balloon.According the facility during a procedure the foley was 'found between the patient's legs and not in the bladder'.Per the facility a follow up cystoscopy was performed in order to retrieve the foley catheter balloon.The sample has not been returned.No additional information is available.Due to the reported incident and 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.

• Type of Device: TTL1LYR 100%SILI UM MF 16FR SAFES
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 13772521
• MDR Text Key: 287249340
• Report Number: 1417592-2022-00036
• Device Sequence Number: 1
• Product Code: OHR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: URO170816SQ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female