MAUDE Adverse Event Report: COOPERSURGICAL, INC. MXAPP TRIMO SAN JEL-JECTOR; TRIMO SAN APPLICATOR

Model Number MXAPP

Device Problem Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Date 09/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint condition reported is currently being investigated.Once the investigation is completed a follow up reported will be filed.

Event Description

"patient went to use the applicator and the end was sharp and scrape/cut her on the inside of her vaginal canal." (b)(4).

Manufacturer Narrative

*investigation no sample returned review dhr inspect stock product *analysis and findings an evaluation of the complainant samples could not be conducted since they will not be returned.The applicator assembly is made up of three component parts (the bulb, the flyer and the tube) purchased from and assembled by a supplier.A review of two year complaint history shows some complaints for this issue.A review of the dhr (243208) show no abnormalities.A review of coopersurgical incoming inspection records of the tube over the past 2 years shows no rejections for this issue.The tube is molded by a supplier and has 8 cavities.A sample inspection of all 8 cavities in stock inventory found all the parts met quality requirements and were not sharp at the distal end.The reported complaint could not be confirmed.*correction and/or corrective action / *preventative action activity will continue to monitor for trending.

Event Description

"patient went to use the applicator and the end was sharp and scrape/cut her on the inside of her vaginal canal." reference e-complaint (b)(4).

• Brand Name: MXAPP TRIMO SAN JEL-JECTOR
• Type of Device: TRIMO SAN APPLICATOR
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 7966334
• MDR Text Key: 123948921
• Report Number: 1216677-2018-00052
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/15/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MXAPP
• Device Catalogue Number: MXAPP
• Device Lot Number: 6628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/25/2018
• Initial Date FDA Received: 10/15/2018
• Supplement Dates Manufacturer Received: 09/25/2018
• Supplement Dates FDA Received: 02/14/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other