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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
Device Problem Difficult to Remove (1528)
Patient Problems Abdominal Pain (1685); Cramp(s) /Muscle Spasm(s) (4521)
Event Date 10/10/2021
Event Type  malfunction  
Manufacturer Narrative
Records demonstrate that quality system procedures were correctly followed and the finished product met all quality release criteria and specifications were within allowable limits prior to release.
 
Event Description
Consumer reported she had pain with the insertion of a bladder support and attempted to remove it right away but could not find the string to remove it.The bladder support remained inside her vaginal cavity for two days.She stated she had been trying to remove it herself and could feel the bladder support inside but could not get a grip on it to remove it.She called and spoke with a nurse who told her she could not do anything for her without a doctor's order.During the last contact with the consumer, she stated she was getting ready to go to the er to have the impressa removed.She reported she was experiencing abdominal pain and cramping in her back.Multiple attempts have been made to obtain further information regarding the consumer¿s use of the product and outcome, however, no further information has been received.
 
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Brand Name
POISE IMPRESSA : PESSARY, VAGINAL : HHW
Type of Device
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
Manufacturer (Section G)
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
Manufacturer Contact
emily arnould, rn bsn
2100 winchester rd
neenah, WI 54956
9207213128
MDR Report Key12771475
MDR Text Key280478047
Report Number3011109575-2021-00639
Device Sequence Number1
Product Code HHW
UDI-Device Identifier00036000496208
UDI-Public036000496208
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131198
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/08/2021
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 Lay User/Patient
Device Model NumberSIZE 3
Device Lot NumberNN033271A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/12/2021
Initial Date FDA Received11/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/27/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age74 YR
Patient SexFemale
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