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

Model Number SIZE 2

Device Problems Product Quality Problem (1506); Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Date 10/01/2016

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 petals from the pessary insertion tube were open and one of the petals was sharp and caused lacerations and bleeding upon insertion.She did not seek medical attention and has recovered.

• 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 Key: 9628601
• MDR Text Key: 176291040
• Report Number: 3011109575-2020-00488
• Device Sequence Number: 1
• Product Code: HHW
• UDI-Device Identifier: 00036000998467
• UDI-Public: 00036000998467
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131198
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SIZE 2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 68 YR