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 Problem Use of Device Problem (1670)

Patient Problems Bacterial Infection (1735); Pain (1994); Fungal Infection (2419); Intermenstrual Bleeding (2665)

Event Date 07/20/2020

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.The poise impressa bladder support product labeling states do not use bladder support during sexual intercourse.The labeling also specifies to not use the bladder support more than 12 hours in a 24 hour period.The consumer left the product in for 16 months and had intercourse while the device was inserted.

Event Description

Consumer reported a bladder support was inadvertently retained in her vaginal cavity for 16 months.On (b)(6) 2019, the consumer inserted the bladder support.Later that day, her preexisting pneumonia symptoms worsened and she was admitted to the hospital.She was sedated, had a urinary catheter inserted, and was treated in the icu.The consumer was hospitalized for approximately eight days.During her hospital stay and subsequent months after, the consumer had forgotten she had inserted the bladder support.During the summer of 2019, she began to experience light pink vaginal bleeding while wiping and dark red vaginal bleeding during intercourse.In (b)(6) 2019, she was seen by her healthcare provider and diagnosed with a yeast infection.An unspecified medication was prescribed but her yeast infection never fully resolved.In (b)(6) 2020, she began to experience vaginal pain.In (b)(6) 2020 she had a vaginal exam and was diagnosed with a bacterial infection and placed on antibiotics.During the vaginal exam, the healthcare provider discovered a hard foreign material in her vaginal cavity.A vaginal ultrasound and a cat scan were performed which confirmed a foreign object.On (b)(6) 2020, a specialist performed a vaginal exam and removed the foreign material which was identified as the bladder support.She experienced pain upon removal but the pain improved after it was removed.No further medical treatment was needed.The consumer confirmed the string was intact upon use.She stated that she forgot about using the product because of the need to be hospitalized for a preexisting unrelated illness.

• 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: 10403410
• MDR Text Key: 203488152
• Report Number: 3011109575-2020-01700
• Device Sequence Number: 1
• Product Code: HHW
• UDI-Device Identifier: 00036000998450
• UDI-Public: 00036000998450
• 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: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SIZE 1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/13/2020
• 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): Required Intervention
• Patient Age: 47 YR