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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. SHAATZ PESSARY 2-3/4
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COOPERSURGICAL, INC. SHAATZ PESSARY 2-3/4 Back to Search Results
Model Number MXPSH2-3/4
Device Problems Difficult to Insert (1316); Material Too Rigid or Stiff (1544)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/23/2020
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical inc.Is currently investigating the reported complaint condition.(b)(4).
 
Event Description
Report stated - "issue with each of them pertaining to texture (to hard), color, stiffness, ease of use.The customer has had ongoing issue with the listed pessaries not being able to insert." (b)(4).Shaatz pessary 2-3 4 mxpsh2-3 4.
 
Manufacturer Narrative
Investigation: x-initiated manufacturer's investigation; x-review dhr; x-inspect stock product.Analysis and findings e-complaint (b)(4).Distribution history the complaint product was manufactured at csi in november 2018 under work order (b)(4).Manufacturing record review (b)(4).Was reviewed and no non-conformities, related to the complaint condition, were noted.Historical complaint review a review of the 2-year complaint history did not show any complaints for this issue.Root cause the shaatz pessary is molded at csi as a gellhorn pessary.A secondary operation removes the stem to make it a shaatz pessary.Quality engineering, manufacturing, marketing, and product surveillance conducted an investigation into the recent complaints regarding the hardness and rigidity of the pessary product line.There have been no specification changes in the last 2 years.Returned product from historical complaint investigations and sample product from finished goods inventory were evaluated and the reported condition could not be duplicated.The products were found to meet all approved release specifications.It should be noted that this product was originally manufactured for coopersurgical by a supplier (eis) until mid-2017.Manufacturing was moved to coopersurgical and validated in (b)(6) of 2017 (b)(6), using a new silicone supplier.It is suspected the customer noticed the current production pessary was slightly harder than the previously received supplier pessary.It should also be noted that the current silicone supplier provides certifications on every shipment with durometer hardness testing per astm (b)(4), which verifies durometer specifications are met.Based upon an analysis of historical returned/complaint product, stock product, dhr review and certificates of conformance, the reported complaint condition could not be confirmed.Correction and/or corrective action capa 735 has been opened to determine if customer observations with regard to pessary durometer warrant further product enhancements.
 
Event Description
Report stated - "issue with each of them pertaining to texture (to hard), color, stiffness, ease of use.The customer has had ongoing issue with the listed pessaries not being able to insert." ref e-complaint (b)(4).1216677-2020-00115, shaatz pessary 2-3 4 mxpsh2-3 4 e-complaint (b)(4).
 
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Brand Name
SHAATZ PESSARY 2-3/4
Type of Device
SHAATZ PESSARY 2-3/4
Manufacturer (Section D)
COOPERSURGICAL, INC.
95 corporate drive
trumbull, ct
MDR Report Key10002244
MDR Text Key194944153
Report Number1216677-2020-00115
Device Sequence Number1
Product Code HHW
Combination Product (y/n)N
PMA/PMN Number
K904774
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 06/30/2020
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 Expiration Date11/02/2023
Device Model NumberMXPSH2-3/4
Device Catalogue NumberMXPSH2-3/4
Device Lot Number250088
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/06/2020
Initial Date FDA Received04/27/2020
Supplement Dates Manufacturer Received04/06/2020
Supplement Dates FDA Received07/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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