MAUDE Adverse Event Report: COOPERSURGICAL, INC. TRIMO SAN

Model Number MX5030

Device Problem Insufficient Information (3190)

Patient Problem Urinary Tract Infection (2120)

Event Date 07/01/2015

Event Type  Other  

Event Description

Consumer diagnosed with urinary tract infection.Reference e-complaint number: (b)(4).

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.The device involved in the complaint has not been returned by the customer for evaluation.Once the investigation is completed a follow-up report will be filed.Reference e-complaint number: (b)(4).

• Brand Name: TRIMO SAN
• Type of Device: TRIMO SAN
• Manufacturer (Section D): COOPERSURGICAL, INC.; trumbull CT
• Manufacturer Contact: nana banafo ; 75 corporate drive; trumbull, CT 06611
• MDR Report Key: 4938245
• MDR Text Key: 6190799
• Report Number: 1216677-2015-00051
• Device Sequence Number: 1
• Product Code: KMJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MX5030
• Device Catalogue Number: MX5030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/01/2015
• Initial Date FDA Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1