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 Break (1069); Material Separation (1562)

Patient Problem Burning Sensation (2146)

Event Date 10/05/2020

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 she went to remove the pessary and found the string detached in her underwear and the pessary was still inside her vaginal cavity.She attempted to manually remove the pessary and scratched herself which caused some spotting and vaginal burning sensation.She was unable to remove the pessary on her own and went to the er.The er doctor removed the pessary.She did not experience any adverse health effects and did not receive any additional medical treatment.She reported the spotting and burning sensation resolved.

Manufacturer Narrative

New information: b5: three companion samples were returned by the consumer.The string on one bladder support was in two pieces, but still attached to the bladder support.No product defects or abnormalities were observed with the other two bladder supports.

Event Description

Three companion samples were returned by the consumer.The string on one bladder support was in two pieces, but still attached to the bladder support.No product defects or abnormalities were observed with the other two bladder supports.

• 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
• MDR Report Key: 10692935
• MDR Text Key: 211757482
• Report Number: 3011109575-2020-01771
• Device Sequence Number: 1
• Product Code: HHW
• UDI-Device Identifier: 00036000496185
• UDI-Public: 036000496185
• 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: 11/04/2020

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: NN932371A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• Supplement Dates FDA Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR