MAUDE Adverse Event Report: COOPERSURGICAL, INC. INCONT DISH W/SP-65MM #2

Model Number MXPCONDS02

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/05/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

"ordered a new 65mm dish for her patient, as the old one ripped during removal.She inserted the pessary and soon the patient returned to the clinic because she was bleeding.".

Manufacturer Narrative

It has been approximately 55 days and the reported sample has not been returned for investigative analysis.This product is molded and packaged at coopersurgical.The reported lot number was produced in april 2018.A review of the dhr did not show any abnormalities.A review of two year complaint history shows no complaints.The reported lot number has been depleted from finished goods inventory.A sampling of current finished goods inventory did not find any mixed product.It should be noted that as part of the bagging process: prior to placing in the bag, each piece is 100% inspected for size by a vision system.There have not been any recent changes to process or specifications.The reported complaint could not be confirmed.

Event Description

Complainant ordered another pessary, which was even larger than the first replacement, though it was also marked 70mm.It also made the patient bleed.Incont dish w-sp-65mm -2 mxpconds02 (b)(4).

• Brand Name: INCONT DISH W/SP-65MM #2
• Type of Device: INCONT DISH W/SP-65MM #2
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPER SURGICAL, INC; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 8448479
• MDR Text Key: 139967013
• Report Number: 1216677-2019-00132
• Device Sequence Number: 1
• Product Code: HHW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K904774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 04/20/2023
• Device Model Number: MXPCONDS02
• Device Catalogue Number: MXPCONDS02
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other