Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. GELLHORN PESS.FLEX.2-1/2
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOPERSURGICAL, INC. GELLHORN PESS.FLEX.2-1/2 Back to Search Results
Model Number MXPGE2-1/2
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).Gellhorn pess flex 2-1 2 mxpge2-1 2.
 
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).1216677-2020-00108 gellhorn pess flex 2-1 2 mxpge2-1 2 e-complaint-(b)(4).
 
Manufacturer Narrative
Investigation: x-initiated manufacturer's investigation.X-review dhr.X-inspect stock product.Analysis and findings: ref:e-complaint-(b)(4).Distribution history: the complaint product was manufactured at csi in (b)(6) 2018 under work order 249353.Manufacturing record review dhr18mpg002961 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.Historical complaint review a review of the 2-year complaint history did show some other complaints for this issue.Root cause 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 november 2017 (val-16-0219) 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 d2240 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.Corrective action: capa 735 has been opened to determine if customer observations with regard to pessary durometer warrant further product enhancements.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GELLHORN PESS.FLEX.2-1/2
Type of Device
GELLHORN PESS.FLEX.2-1/2
Manufacturer (Section D)
COOPERSURGICAL, INC.
95 corporate drive
trumbull, ct
MDR Report Key9997872
MDR Text Key194942446
Report Number1216677-2020-00108
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 07/26/2020
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 Model NumberMXPGE2-1/2
Device Catalogue NumberMXPGE2-1/2
Device Lot Number249353
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 03/24/2020
Initial Date FDA Received04/24/2020
Supplement Dates Manufacturer Received03/24/2020
Supplement Dates FDA Received07/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-