MAUDE Adverse Event Report: COOK INC. DISPOSABLE CHECK-FLO ADAPTER; LAPAROSCOPE, GYNECOLOGIC

Catalog Number 050885 G15476

Device Problem Fluid/Blood Leak (1250)

Patient Problem Exposure to Body Fluids (1745)

Event Date 06/12/2019

Event Type  malfunction  

Event Description

Product leaking fluid from bladder during procedure exposing physician to pt bodily fluids.

• Brand Name: DISPOSABLE CHECK-FLO ADAPTER
• Type of Device: LAPAROSCOPE, GYNECOLOGIC
• Manufacturer (Section D): COOK INC.
• MDR Report Key: 9245122
• MDR Text Key: 164287679
• Report Number: MW5090708
• Device Sequence Number: 1
• Product Code: HET
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2022
• Device Catalogue Number: 050885 G15476
• Device Lot Number: 9659349
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR