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

Device Problem Break (1069)

Patient Problems Pain (1994); Perforation (2001); Urinary Tract Infection (2120); Ambulation Difficulties (2544)

Event Date 07/01/2019

Event Type  Injury  

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 she inserted a pessary three years ago then she was unable to find string during removal.She thought the string fell off during use and manually felt inside for pessary and did not feel it.After this, she stopped using impressa and continued using poise pads.Six months later she began to experience vaginal odor, difficulty walking and back pain.She saw her doctor and was diagnosed with a bladder infection.She was prescribed with cipro.The bladder infection resolved.A week later, the bladder infection came back.Cipro was prescribed.She experienced reoccurring bladder infection for about a year.She began to experience constant urinary leakage and was referred to a urogynecologist who found she had a perforated bladder and a possible growth on her cervix.She then saw gynecological oncologist.The doctor found no cancer growth but an impressa inside of her.The impressa was lodged in her cervix and removed by doctor with no string attached during removal.The impressa perforated her bladder which led to constant urinary leakage.Her symptoms resolved after removal of the pessary and her back pain improved.She had a cat scan and was waiting test result and doctor to decide what will be done with her perforated bladder.She was still experiencing urinary incontinence and pain.

• 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: chris maertz ; 2100 winchester rd; neenah, WI 54956 ; 9207214907
• MDR Report Key: 8945507
• MDR Text Key: 156582749
• Report Number: 3011109575-2019-01464
• Device Sequence Number: 1
• Product Code: HHW
• 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: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/06/2019
• 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 Outcome(s): Other
• Patient Age: 73 YR