MAUDE Adverse Event Report: COOPERSURGICAL, INC. KIT-RING W/SUPP.#5 76MM

Model Number MXKPRS05

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

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Dysuria (2684); Dyspareunia (4505)

Event Date 10/12/2020

Event Type  malfunction  

Manufacturer Narrative

Cooper surgical, inc.Is currently investigating the reported condition.

Event Description

E-complaint: (b)(4).Incident report : every 3 months patient returns to (b)(6) to remove, clean and reinsert pessary.Upon removal patient experiences excruciating pain, slight bleeding, painful urination, painful intercourse for approximately 3 days following.This is the 4th time completing the removal and reinsertion process, this has occurred each time.Last visit to physician was (b)(6) 2020.(b)(4).

Event Description

Report stated: "every 3 months patient returns to [physician] to remove, clean and reinsert pessary.Upon removal patient experiences excruciating pain, slight bleeding, painful urination, painful intercourse for approximately 3 days following.This is the 4th time completing the removal and reinsertion process, this has occurred each time." 1216677-2020-00242-1 mxkprs05 kit-ring w supp 5 76mm e-complaint (b)(4).

Manufacturer Narrative

Investigation no sample returned distribution history distribution history could not be determined as the lot number was not provided.Should the complaint product lot number be provided going forward, the distribution history will be reviewed, and this complaint amended accordingly.Manufacturing record review a review of the device history record could not be performed because the lot/serial number was not provided.However, it should be noted at the time of manufacture records from each lot are thoroughly reviewed to ensure that products are released meeting all coopersurgical quality release specifications.Should the complaint product lot/serial number be provided going forward, the device history record will be reviewed, and this complaint amended accordingly.Incoming inspection review incoming inspection record review not applicable to this product.Service history record service history not applicable for this product.Historical complaint review a review of the 2-year complaint history did not show similar reported complaint conditions.Product receipt the complaint product has not been returned to coopersurgical.Visual evaluation evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Root cause root cause not applicable as the complaint condition was not confirmed.Corrective actions coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.No further training required at this time.Was the complaint confirmed? no.

• Brand Name: KIT-RING W/SUPP.#5 76MM
• Type of Device: KIT-RING W/SUPP.#5 76MM
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 10719065
• MDR Text Key: 215027386
• Report Number: 1216677-2020-00242
• Device Sequence Number: 1
• Product Code: HHW
• UDI-Device Identifier: 00888937008715
• UDI-Public: 888937008715
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K904774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MXKPRS05
• Device Catalogue Number: MXKPRS05
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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