MAUDE Adverse Event Report: COOPERSURGICAL, INC. TRIMO SAN

Model Number MX5030

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 02/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient states they are allergic to the trim-san jelly.Advised she purchased at (b)(6).Patient was advised to contact their medical provider to alert of any adverse effects.Patient states they have no interest in doing so.Patient only looking for reimbursement of the product.

• Brand Name: TRIMO SAN
• Type of Device: TRIMO SAN
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: peter niziolek ; 75 corporate drive; trumbull, CT 06611
• MDR Report Key: 8377776
• MDR Text Key: 137397673
• Report Number: 1216677-2019-00105
• Device Sequence Number: 1
• Product Code: HGD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: E216669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial

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 Operator: Lay User/Patient
• Device Model Number: MX5030
• Device Catalogue Number: MX5030
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 02/28/2019
• 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