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

Model Number	SIZE 1
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Skin Inflammation/ Irritation (4545)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Records demonstrate that quality system procedures were correctly followed and the finished product met all quality release criteria and specifications were within allowable limits prior to release.
Event or Problem Description
Consumer reported that during wear the string had come off of her bladder support leaving the device inside her vaginal cavity.A few days later she went to her healthcare provider for removal of the bladder support.Her doctor removed the bladder support and stated she had external and internal irritation.Consumer described the irritation as burning with bloody vaginal discharge.Her doctor prescribed oral antibiotics metronidazole and doxycycline monohydrate and performed diagnostic tests.The doctor stated he thought she had a vaginal infection.Since taking the antibiotics her symptoms improved and she was awaiting a follow up call from her doctor.

• Brand Name: POISE IMPRESSA : PESSARY, VAGINAL : HHW
• Common Device Name: 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: 12348276
• Report Number: 3011109575-2021-00459
• Device Sequence Number: 4181792
• Product Code: HHW
• UDI-Device Identifier: 00036000496185
• UDI-Public: 036000496185
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: SIZE 1
• Device Lot Number: NN005771A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR