MAUDE Adverse Event Report: COOPERSURGICAL, INC. RING W/SUPP.#6 83MM 3-1/4

Model Number MXPRS06

Device Problems Difficult to Insert (1316); Positioning Problem (3009)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Genital Bleeding (4507)

Event Date 06/14/2018

Event Type  malfunction  

Manufacturer Narrative

Cooper surgical inc.Is currently investigating the reported complaint condition.The device involved in the complaint has not yet been returned by the customer for evaluation.Once the device is received by cooper surgical inc.The investigation will be completed and a follow-up report will be filed.(b)(4).

Event Description

"this new pessary was too stiff and after three tries her gynecologist could not insert it" "she tried 3 times to insert pessary but it would not go into place and every time she was hurting me and i was bleeding.So she stops." two mxprs06 pessaries were purchased by the above account however since the product is not being returned we can not definitively determine which of the two was the product involved in the incident.Lot # 227732 or 227730.(b)(4).

Manufacturer Narrative

Clarification to h.6.Component code: unit is a one-piece pessary.Clarification to d.3.Lot number: lot # 227732 and 227730 were identified as possible lot numbers for the complaint product.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 july/early august 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.

Event Description

Patient reported "this new pessary was too stiff and after three tries her gynecologist could not insert it," "she tried 3 times to insert pessary but it would not go into place and every time she was hurting me and i was bleeding.So she stops." (b)(4).

• Brand Name: RING W/SUPP.#6 83MM 3-1/4
• Type of Device: RING W/SUPP.#6 83MM 3-1/4
• 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: 8025942
• MDR Text Key: 125936543
• Report Number: 1216677-2018-00067
• 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
• 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: 10/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MXPRS06
• Device Catalogue Number: MXPRS06
• 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
• 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