MAUDE Adverse Event Report: COOPERSURGICAL, INC. SHAATZ PESS 3-1/4

Model Number MXPSH3-1/4

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currenlty investigating the reportred condition.

Event Description

Ref e-complaint (b)(4).Report forwarded by customer service trumbull the customer has issued a customer dissatisfaction complaint some time ago saying the pessaries are too stiff.Additional complaint in ref.To e-complaint (b)(4) shaatz pessary 2-1 4 mxpsh2-1 4 e-complaint (b)(4).

Manufacturer Narrative

Investigation: initiated manufacturer's investigation; no sample returned, review dhr, inspect stock product.Distribution history: the complaint product was manufactured at csi in february 2020 under work order (b)(4).Manufacturing record review: dhr20mpg001389 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 show one other complaint for this issue.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.Corrective actions: coopersurgical decided to return manufacturing to the supplier (eis) in late 2020.Long stem gellhorns were qualified per val-20-0285 and short stem gellhorn pessaries were qualified per val-20-0289.As stated previously, a secondary operation removes the stem to make it a shaatz pessary.In addition, the prints for the gellhorn pessaries were updated to reduce the durometer hardness from 60 to 45.Was the complaint confirmed? no.

Event Description

"the customer has issued a customer dissatisfaction complaint some time ago saying the pessaries are too stiff".1216677-2020-00278-1 mxpsh3-1-4-shaatz pess 3-1-4 (b)(4).

• Brand Name: SHAATZ PESS 3-1/4
• Type of Device: SHAATZ PESS 3-1/4
• 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 dr; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 10881776
• MDR Text Key: 245492603
• Report Number: 1216677-2020-00278
• Device Sequence Number: 1
• Product Code: HHW
• UDI-Device Identifier: 00888937008715
• UDI-Public: 888937008715
• 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,Company Representative,Distributor
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MXPSH3-1/4
• Device Catalogue Number: MXPSH3-1/4
• Device Lot Number: 277473
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 11/22/2020
• Supplement Dates Manufacturer Received: 06/30/2020
• Supplement Dates FDA Received: 02/08/2023
• 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