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

Model Number MX5030

Device Problem Insufficient Information (3190)

Patient Problem Abrasion (1689)

Event Date 04/01/2019

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

"ordered trimosan from (b)(6).Said applicator scratched her did not give details." (b)(4).

Event Description

"ordered trimosan from walmart.Com.Said applicator scratched her did not give details." reference e-complaint-(b)(4).

Manufacturer Narrative

Reference e-complaint-(b)(4).Investigation: x-no sample returned, x-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 no complaints for this issue.The complainant did not disclose a lot number.A review of coopersurgical incoming inspection records shows no rejections for this issue.The tube is molded by a supplier and has 8 cavities.A sample 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; none.No action is required at this time.Continue to monitor for trending.Should the samples be returned, this complaint will be reopened and re-evaluated.Preventative action activity: coopersurgical will continue to monitor this complaint condition for any trends.

• Brand Name: MX5030 TRIMO SAN
• Type of Device: TRIMO SAN
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8508461
• MDR Text Key: 141937953
• Report Number: 1216677-2019-00055
• Device Sequence Number: 1
• Product Code: HGD
• Combination Product (y/n): N
• PMA/PMN Number: E216669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 12/12/2019

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: MX5030
• Device Catalogue Number: MX5030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/12/2019
• Supplement Dates Manufacturer Received: 04/01/2019
• Supplement Dates FDA Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other