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

Model Number MIL0075

Device Problem Sharp Edges (4013)

Patient Problems Pain (1994); Blood Loss (2597)

Event Date 08/29/2019

Event Type  malfunction  

Manufacturer Narrative

Reference e-complaint (b)(4).The complaint condition reported is currently being investigated.Once the investigation is completed a follow up reported will be filed.

Event Description

Per fax report -customer stated end of applicator seem to sharp and hurts inside of vagina causing slight bleeding.Reference e-complaint (b)(4).

Manufacturer Narrative

Reference e-complaint-(b)(4).Investigation: x-no sample returned and 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: no corrective action is required at this time.Will continue to monitor for trending.Should the samples be returned, this complaint will be reopened and re-evaluated.Was the complaint confirmed? no.Preventative action activity: coopersurgical will continue to monitor this complaint condition for any trends.

Event Description

Per fax report -customer stated end of applicator seem to sharp and hurts inside of vagina causing slight bleeding.Reference e-complaint-(b)(4).

• Brand Name: JEL-JECTOR,APPLICATOR
• Type of Device: TRIMO SAN APPLICATOR
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 9110907
• MDR Text Key: 190542373
• Report Number: 1216677-2019-00263
• Device Sequence Number: 1
• Product Code: HGD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 12/23/2019

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: MIL0075
• Device Catalogue Number: MIL0075
• Device Lot Number: NONE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 09/24/2019
• Supplement Dates Manufacturer Received: 09/04/2019
• Supplement Dates FDA Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other