MAUDE Adverse Event Report: K-C AFC MANUFACTURING, S. DE R.L. DE C.V POISE IMPRESSA : PESSARY, VAGINAL : HHW

Model Number SIZE 1

Device Problem Material Separation (1562)

Patient Problems Genital Bleeding (4507); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 10/25/2022

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

This is a non-us event.This occurred in canada.Consumer reported after insertion of a bladder support she noticed the string was missing.The next day she went to her doctor who did an internal vaginal exam and no bladder support was located inside.She experienced bleeding during the exam and her provider advised using a heating pad.She also experienced cramping which has improved.

• 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; 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; nogales, sonora mexico 84094 ; MX 84094
• Manufacturer Contact: emily arnould, rn bsn ; 2100 winchester rd; neenah, WI 54956 ; 9207213128
• MDR Report Key: 15839561
• MDR Text Key: 304103522
• Report Number: 3011109575-2022-00465
• Device Sequence Number: 1
• Product Code: HHW
• UDI-Device Identifier: 00036000496239
• UDI-Public: 036000496239
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131198
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2022

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 Number: SIZE 1
• Device Lot Number: NN822061A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2022
• Initial Date FDA Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female