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 Problems Material Separation (1562); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2019

Event Type  malfunction  

Manufacturer Narrative

Review of the device history record (dhr) and supporting quality records confirmed no anomalies that may have caused or contributed to the malfunction.

Event Description

Consumer reported the string pulled out from a pessary prior to use.No further information has been received.

Manufacturer Narrative

New information: b5: this is a follow up to report the consumer stated she also had a pessary from the same box where the string was completely missing.E1: initial reporter name and address.G4: date received.G7: follow-up 10.H2: follow-up type.H6: device code - added 2306 - component missing.

Event Description

This is a follow up to report the consumer stated she also had a pessary from the same box where the string was completely missing.

• 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: 9626790
• MDR Text Key: 177666161
• Report Number: 3011109575-2020-00382
• 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: 02/25/2020

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
• Device Lot Number: NN809571A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 01/24/2020
• Supplement Dates Manufacturer Received: 02/04/2020
• Supplement Dates FDA Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR