MAUDE Adverse Event Report: COOPERSURGICAL, INC. RING PESSARY #5

Model Number MXPER05

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Genital Bleeding (4507)

Event Date 04/23/2018

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.The device involved will not be returned by the customer for evaluation.Once the investigation has been completed a follow-up report will be filed.(b)(4).

Event Description

Patient stated in letter that a size 5 pessary that was inserted on (b)(6) 2017 caused a hemorrhage when being removed for routine monthly cleaning on (b)(6) 2018.The pessary had 3 deep splits around it.The patient went to her family doctor who gave her a prescription for antibiotics because the broken pessary caused an infection.Patient stated "the nurse removed my pessary and said there was some blood on it and went to the sink to clean it and check it over, she said the pessary had 3 deep splits around it and when she turned around i had hemorrhage of the table, there was blood every where on the table, my clothes, the floor" (b)(4).

Manufacturer Narrative

Clarification to h.6.Component code: unit is a one-piece pessary.Investigation: an evaluation of the complainant samples could not be conducted since it will not be returned.A review of two year complaint history shows no complaints.This product is molded and packaged at coopersurgical trumbull facility and is 100% visually inspected prior to packaging.The lot numbers in question were manufactured in june 2017 and sent to the customer in late (b)(6) 2017.Without the returned sample, a definitive root cause of the issue cannot be determined at this time and thus, the complaint is not confirmed.Coopersurgical will continue to monitor for trending.Corrective actions: this complaint will be reopened and re-evaluated should the samples be returned.Will continue to monitor for trending.Additional data: b.1., b.5., d.3., d.4., g.1., g.2., g.3., h.6.

Event Description

Patient stated in letter that a size 5 pessary that was inserted caused a hemorrhage when being removed for routine monthly cleaning.The pessary had 3 deep splits around it.The patient went to her family doctor who gave her a prescription for antibiotics because the broken pessary caused an infection.Patient stated "the nurse removed my pessary and said there was some blood on it and went to the sink to clean it and check it over, she said the pessary had 3 deep splits around it and when she turned around i had hemorrhage of the table, there was blood every where on the table, my clothes, the floor." ref e-complaint(b)(4).

• Brand Name: RING PESSARY #5
• Type of Device: RING PESSARY #5
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 75 corprate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 8042994
• MDR Text Key: 126529000
• Report Number: 1216677-2018-00066
• 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: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2022
• Device Model Number: MXPER05
• Device Catalogue Number: MXPER05
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/22/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/09/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other