MAUDE Adverse Event Report: COOPERSURGICAL, INC. DONUT PESS 2-1/2 INCH #2

Model Number MXPDO02

Device Problem Product Quality Problem (1506)

Patient Problems Abnormal Vaginal Discharge (2123); Irritability (2421)

Event Date 07/15/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.

Event Description

Report state "patient has advised practitioner of the following: i noticed on taking out the donut pessary over the last 1 1/2 weeks that the edge is rough.The donut itself looks as if it was manufactured and had excess silicone all around the middle of it and the excess has been shaved off.If you cut the donut in half horizontally and then glued it together, all along the glue line it is rough and not like the rest of the surface.It's not smooth and i am wondering two things, is this normal or a defect? our test one was completely smooth.Is it irritating me? i'll take a picture of it and send it to you as well.Not sure if this will show up as it is texture." patient status-irritation.Purchase order/ invoice #: (b)(4).07/29/2021- follow-up response stated - the patient in question reported: increased vaginal discharge that started out as clear, became creamy/white over the next day or so then took on a yellow colour with a mild odour.There was also an increase in the amount of secretions.As the secretions changed, she also began to notice a vaginal irritation as if there was something rough rubbing along her vaginal walls.She removed the pessary for 3 days once the secretions became yellow.We increased her use of her hyaluronic acid moisturizer to settle any aggravation and no additional medication/ointment was required.There was no additional medical attention required as her secretions quickly returned to normal.Donut pess 2-1 2 inch no 2 mxpdo02 (b)(4).

Event Description

Report state "patient has advised practitioner of the following: i noticed on taking out the donut pessary over the last 1 1/2 weeks that the edge is rough.The donut itself looks as if it was manufactured and had excess silicone all around the middle of it and the excess has been shaved off.If you cut the donut in half horizontally and then glued it together, all along the glue line it is rough and not like the rest of the surface.It's not smooth and i am wondering two things, 1.Is this normal or a defect? our test one was completely smooth 2.Is it irritating me?i'll take a picture of it and send it to you as well.Not sure if this will show up as it is texture." patient status-irritation 07/29/2021- follow-up response stated - the patient in question reported: -increased vaginal discharge that started out as clear, became creamy/white over the next day or so then took on a yellow colour with a mild odour -there was also an increase in the amount of secretions -as the secretions changed, she also began to notice a vaginal irritation as if there was something rough rubbing along her vaginal walls.-she removed the pessary for 3 days once the secretions became yellow -we increased her use of her hyaluronic acid moisturizer to settle any aggravation and no additional medication/ointment was required.-there was no additional medical attention required as her secretions quickly returned to normal 1216677-2021-00157 donut pess 2-1 2 inch no 2 mxpdo02 e-complaint (b)(4).

Manufacturer Narrative

Investigation x-review dhr *analysis and findings e-complaint (b)(4) *was the complaint confirmed? no distribution history the complaint product was manufactured at csi in june 2020 under work order (b)(4).Manufacturing record review (b)(4) 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 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 the complaint product has not been returned, however, the complainant did supply a picture of the product and for the sake of this investigation, it is assumed to be the complaint product.Visual inspection of the picture did not reveal any defects in the product.As part of the process, the two halves of the donut are glued together and then are buffed along the glue line to remove excess material, so this area will be slightly different than the rest of the donut surface.*correction and/or corrective action no further corrective action is necessary, as the complaint condition was not confirmed.No training required at this time.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

• Brand Name: DONUT PESS 2-1/2 INCH #2
• Type of Device: DONUT PESS 2-1/2 INCH #2
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 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: 12328189
• MDR Text Key: 268244467
• Report Number: 1216677-2021-00157
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MXPDO02
• Device Catalogue Number: MXPDO02
• Device Lot Number: 275514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2021
• 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