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

Model Number MXAPP

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Genital Bleeding (4507)

Event Date 03/05/2021

Event Type  malfunction  

Manufacturer Narrative

Coopesurgical , inc.Is currenlty investigating the reported condition.

Event Description

The usage of the applicator feels like glass and has cause some vaginal bleeding.Jel jector applicator mxapp.E-complaint- (b)(4).

Manufacturer Narrative

Investigation x-no sample returned x-review dhr *analysis and findings distribution history the complaint product was purchased from a suppler (carclo) and packaged by csi in december 2020.Manufacturing record review the reported lot number (8320) was used in three work orders ((b)(4)).Dhr's for these work orders were reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review incoming inspection record review not applicable as this product is on ship to stock.A review of ncmr's for the past two years did not show similar reported complaint conditions.Service history record service history not applicable for this product.Historical complaint review a review of the 2-year complaint history did not show similar reported complaint conditions.Product receipt the complaint product has not been returned to coopersurgical.Visual evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Root cause root cause not applicable as the complaint condition was not confirmed.*correction and/or corrective action coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

Event Description

The usage of the applicator feels like glass and has cause some vaginal bleeding.1216677-2021-00065 jel jector applicator mxapp 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: 11649904
• MDR Text Key: 260991022
• Report Number: 1216677-2021-00065
• 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: 11/14/2022

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: 8320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/14/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other