MAUDE Adverse Event Report: COOPERSURGICAL, INC. MX5030 TRIMO SAN

Model Number MX5030

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Abnormal Vaginal Discharge (2123)

Event Date 01/22/2016

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investigation is completed a follow-up report will be filed.(b)(4).

Event Description

Patient reported white cottage cheese chunk vaginal discharge after 4 weeks of use twice weekly for a total of 7 tubes.(b)(4).

Manufacturer Narrative

Reference e-complaint: (b)(4).Investigation, x-initiated manufacturer's investigation, x-no sample returned, review dhr, inspect returned samples, inspect stock product.Analysis and findings: dhr review could not be performed as the subject lot was not provided.A two year review of manufacturing records did not show any related manufacturing issues during the last 2 years.There have not been any related product design or product specification changes in the last two years.Historical review of complaint files did not show any related complaints.A follow up to the secondary reporter, church and dwight, did not yield any additional information.The complainant however indicated she previously did not have any discharge and had used about 7 trimo-san¿ vaginal jelly tubes in a span of 4 weeks prior to the alleged event.The patient was advised by her doctor to reduce the application of the trimo-san¿ vaginal jelly to twice a week to help manage her uterine prolapse.Assignable cause could not be determined based on the information provided.There was no patient injury reported.There has not been any additional information received since.Based on overall complaint history, product knowledge, and the reported complaint condition, it is unlikely the reported complaint condition would result in any adverse event.The discharge may have been due to over application of the trimo-san¿ vaginal jelly.No further actions are needed at this time.Coopersurgical will continue to monitor complaints of this nature for any adverse trends.Correction and/or corrective action: no further actions are needed at this time.Corrective action level: 4, x-none.Was the complaint confirmed? no.Review and closure.Preventative action activity reviewed.Trend and monitor to cip.

Event Description

Patient reported white cottage cheese chunk vaginal discharge after 4 weeks of use twice weekly for a total of 7 tubes.Reference e-complaint number: (b)(4).

• Brand Name: MX5030 TRIMO SAN
• Type of Device: MX5030 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: nana banafo ; 75 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 5614242
• MDR Text Key: 44579637
• Report Number: 1216677-2016-00014
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2016

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: Physician
• Device Model Number: MX5030
• Device Catalogue Number: MX5030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other