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 Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2017

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 the string pulled out of a bladder support upon opening the wrapper.She did not use the bladder support.

Manufacturer Narrative

Corrected information: b1: remove product problem.B5: this is a follow up to mdr 3011109575-2020-01639 which was submitted as a string product malfunction.Upon further review of complaint, it was determined that the consumer physically damaged the product string while opening the individual wrapper.Since mishandling of the packaging occurred, this is not considered a product malfunction.G7: follow up 1.H2: correction, additional information.

Event Description

This is a follow up to mdr 3011109575-2020-01639 which was submitted as a string product malfunction.Upon further review of complaint, it was determined that the consumer physically damaged the product string while opening the individual wrapper.Since mishandling of the packaging occurred, this is not considered a product malfunction.

• 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: 10018942
• MDR Text Key: 189652785
• Report Number: 3011109575-2020-01639
• 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: 01/26/2017
• Initial Date FDA Received: 05/01/2020
• Supplement Dates Manufacturer Received: 06/15/2020
• Supplement Dates FDA Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR