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

Model Number MXAPP

Device Problem Material Integrity Problem (2978)

Patient Problem Blood Loss (2597)

Event Date 07/27/2016

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.The device involved in the complaint has not yet been returned by the patient for evaluation.Once this investigation is completed a follow-up report will be filed.Reference e-complaint: (b)(4).

Event Description

Per complainant trimosan applicator is sharp and caused bleeding during use."light blood" i called my doctor , he didn't seem concerned." told me to put some on my finger and put it up there ".Ref e-complaint: (b)(4).

Manufacturer Narrative

(b)(4).Investigation: initiated manufacturer's investigation.No sample returned.Review dhr: inspect returned samples.Inspect stock product.Analysis and findings: the returned sample was visually inspected and found not to have any sharp edges on the outside diameter or tip of the tube.The applicator is made up of three component parts (the bulb, the flyer and the tube) purchased and assembled by a supplier.For this complaint, a lot number was not furnished.A review of two year complaint history shows no complaints for this issue.In addition, a sample of applicators from inventory were visual inspected and there were no sharp edges on the outside diameter or tip of the applicator tube.The complaint could not be confirmed.Correction and/or corrective action: will continue to monitor for trending.Corrective action level 4: train personnel: none.Was the complaint confirmed? no.Review and closure: recommended continuous improvement program (cip).Complaint closure letter required? ncmr issued? preventative action activity reviewed.Trend and monitor to cip.

Event Description

Per complainant, trimosan applicator is sharp and caused bleeding during use."light blood" i called my doctor, he didn't seem concerned." " told me to put some on my finger and put it up there ".(b)(4).

• Brand Name: MXAPP JEL-JECTOR
• Type of Device: TRIMOSAN APPLICATOR
• 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: 6131845
• MDR Text Key: 61351694
• Report Number: 1216677-2016-00060
• Device Sequence Number: 1
• Product Code: HHW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: MXAPP
• Device Catalogue Number: MXAPP
• Device Lot Number: NONE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other