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 Bacterial Infection (1735); Pain (1994); Abnormal Vaginal Discharge (2123)

Event Date 05/11/2017

Event Type  malfunction  

Manufacturer Narrative

A manufacturer lot code was not provided.With no means to ascertain the manufacturer/asset line and day of production, no further investigation on documents and supporting records can be performed.

Event Description

Consumer reported she had forgotten she inserted a bladder support and it was left inside her for three weeks.After three weeks she alleged the bladder support came out sideways.She felt a scratch-like pain on the right side of her vagina and experienced a small amount of vaginal bleeding.She also began to experience a foul vaginal odor and watery beige colored vaginal discharge.She went to the er and during a vaginal exam the emergency physician found and removed two small pieces of string that had been left behind from the bladder support.She was diagnosed with a vaginal infection and prescribed an unspecified antibiotic.She stated she was feeling much better.

Manufacturer Narrative

New information: b5: this is a follow up to clarify the product malfunction was caused by consumer misuse of the poise impressa bladder support.G7: follow up 1.Additional narrative: the consumer left the product in for three weeks and had intercourse while the device was inserted.Poise impressa bladder supports labeling specifies to not use more than 12 hours in a 24 hour period.

Event Description

This is a follow up to clarify the product malfunction was caused by consumer misuse of the poise impressa bladder support.

• 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
• MDR Report Key: 10098542
• MDR Text Key: 193034199
• Report Number: 3011109575-2020-01658
• Device Sequence Number: 1
• Product Code: HHW
• UDI-Device Identifier: 00036000998450
• UDI-Public: 00036000998450
• Combination Product (y/n): N
• PMA/PMN Number: K131198
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/01/2020

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: Lay User/Patient
• Device Model Number: SIZE 1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/11/2017
• Initial Date FDA Received: 05/28/2020
• Supplement Dates Manufacturer Received: 06/16/2020
• Supplement Dates FDA Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR