MAUDE Adverse Event Report: COOPERSURGICAL, INC. TRIMO SAN

Model Number MX5030

Device Problem Scratched Material (3020)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 12/13/2016

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported complaint condition.The device involved in the complaint will not be returned by the patient for evaluation.Once the investigation is complete, a follow up report will be filed.(b)(4).Product will not be returned.

Event Description

(b)(4)."caller stated that she is a user of the device and knew immediately that her applicator has a sharp opening, said she ran her hand across the opening and could feel its sharpness.Customer stated she used it anyway but tried to use it in a way that the could avoid the sharp opening scrapping against her skin but was unfortunate.She is a bit sore border line aching feather line blood.Caller states when wiping a bit of dark tint can be seen caller also stated that she will watch aching for a week and if symptoms are still present she will make an appointment to see obgyn".

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported complaint condition.The device involved in the complaint will not be returned by the patient for evaluation.Once the investigation is complete, a follow up report will be filed.Reference e-complaint (b)(4) *** follow up 02/07/2017 *** investigation: initiated manufacturer's investigation.X-no sample returned.X-review dhr.Inspect returned samples.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.A review of the dhr's ((b)(4)) show no abnormalities.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 should the samples be returned, this complaint will be reopened and re-evaluated.This complaint will be entered into the cooper surgical continuous improvement plan (cip).

Event Description

Reference e-complaint (b)(4)."caller stated that she is a user of the device and knew immediately that her applicator has a sharp opening, said she ran her hang across the opening and could feel its sharpness.Customer stated she used it anyway but tried to use it in a way that the could avoid the sharp opening scrapping against her skin but was unfortunate.She is a bit sore border line aching feather line blood.Caller states when wiping a bit of dark tint can be seen caller also stated that she will watch aching for a week and if symptoms are still present she will make an appointment to see obgyn".

• Brand Name: TRIMO SAN
• Type of Device: 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: 6272560
• MDR Text Key: 65945333
• Report Number: 1216677-2017-00002
• Device Sequence Number: 1
• Product Code: HGD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2018
• Device Model Number: MX5030
• Device Catalogue Number: MX5030
• Device Lot Number: 5890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2016
• Initial Date FDA Received: 01/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: No
• 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