MAUDE Adverse Event Report: COOPERSURGICAL, INC. KIT-FLEX.GELLH.2-3/4

Model Number MXKPGE2-3/4

Device Problems Material Discolored (1170); Material Erosion (1214); Difficult to Remove (1528); Microbial Contamination of Device (2303)

Patient Problem Ulcer (2274)

Event Date 05/13/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.(b)(4).

Event Description

Complaint submitted by csi rep- incident report : one of our patients had a gellhorn 2.75 pessary inserted in february and when she came in for the exam and cleaning, it was eroded and also had what looked to be mold on the knob and the top portion as well.When pessary was removed in clinic it was the first time it had been removed and an attempt at cleaning it was made.The places where it was eroded also had black markings in the grooves of the actual erosion.Attached are some photos of the pessary after it was removed and an attempt at cleaning it was made.06-10-2020- updated with complaint form.Additional info - patient presented for a routine pessary check.Upon removal, the device appeared degraded with black discoloration.Pessary removal difficult, patient with multiple vaginal ulcers upon removal.Patient receiving ongoing treatment.(b)(4).

Manufacturer Narrative

Investigation initiated manufacturer's investigation review dhr inspect returned samples distribution history the complaint product was manufactured at csi in september 2019 under work order (b)(4).Manufacturing record review dhr19mpg005578 was reviewed and no non-conformities, related to the complaint condition, were noted.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 been returned to coopersurgical.Visual evaluation a visual inspection of the returned product found black marks on various parts of the pessary.The pessary itself did not exhibit any signs of degradation or erosion (such as grooves or channels).Functional evaluation a functional evaluation of the returned product found the pessary to function properly.Root cause the pessary itself did not exhibit any signs of degradation or erosion and functioned properly.Since the pessary was inside the patient for an extended period of time and this is the first time it was removed from the patient, it is suspected the black marks may be some type of bacteria due to lack of cleaning in a timely manner.Corrective actions coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary at this time.No training required at this time.Was the complaint confirmed? yes.

Event Description

Report stated: "one of our patients had a gellhorn 2.75 pessary inserted in february and when she came in for the exam and cleaning, it was eroded and also had what looked to be mold on the knob and the top portion as well.When pessary was removed in clinic it was the first time it had been removed and an attempt at cleaning it was made.Mxkpge2-3 4kit-flex gellh 2-3 4 e-complaint (b)(4).

• Brand Name: KIT-FLEX.GELLH.2-3/4
• Type of Device: KIT-FLEX.GELLH.2-3/4
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 10168847
• MDR Text Key: 199683002
• Report Number: 1216677-2020-00131
• Device Sequence Number: 1
• Product Code: HHW
• 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: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: MXKPGE2-3/4
• Device Catalogue Number: MXKPGE2-3/4
• Device Lot Number: 249461
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2019
• 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