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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K-C AFC MANUFACTURING, S. DE R.L. DE C.V POISE IMPRESSA : PESSARY, VAGINAL : HHW
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K-C AFC MANUFACTURING, S. DE R.L. DE C.V POISE IMPRESSA : PESSARY, VAGINAL : HHW Back to Search Results
Model Number SIZE 3
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/01/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Review of the device history record (dhr) and supporting quality records confirmed no anomalies that may have caused or contributed to the malfunction.
 
Event or Problem Description
Consumer reported upon removal the string broke leaving the pessary inside her vaginal cavity.She manually removed the pessary and did not seek medical attention.She did not experience any adverse health effects.
 
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Brand Name
POISE IMPRESSA : PESSARY, VAGINAL : HHW
Common Device Name
PESSARY, VAGINAL
Manufacturer (Section D)
K-C AFC MANUFACTURING, S. DE R.L. DE C.V
calzada industrial de las maquiladoras #87
nuevo nogales
nogales, sonora mexico 84094
MX  84094
MDR Report Key10550762
Report Number3011109575-2020-01741
Device Sequence Number3216379
Product Code HHW
UDI-Device Identifier00036000496208
UDI-Public036000496208
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K131198
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 09/17/2020
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
Operator of Device Lay User/Patient
Device Model NumberSIZE 3
Device Lot NumberNN933771A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/09/2020
Initial Report FDA Received Date09/17/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age64 YR
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