MAUDE Adverse Event Report: NEENAH COLD SPRING FACILITY POISE PADS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ

Model Number MODERATE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 06/17/2022

Event Type  Injury  

Event Description

The consumer's grandmother reported that the 15 year old consumer had been wearing poise pads for approximately three weeks post back surgery for urinary incontinence.On (b)(6) 2022, after wearing a pad all day with no incontinence noted, she experienced pain and swelling in her labia area.She applied ice packs to the affected area, which did not reduce the swelling.The following morning, she was admitted to the emergency room where she was treated with oral and iv benadryl, which were ineffective in relieving the swelling.Her labia was swollen, blistered and bumpy.She was admitted to the hospital on (b)(6) 2022 where she received intermittent iv fluids, tylenol and ibuprofen for pain, topical steroid cream for swelling, and additional diagnostic procedures.Infection as a cause was ruled out.She was discharged home on (b)(6) 2022 with an undetermined diagnosis.It was reported that the consumer's health status was improved at the time of hospital discharge.

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.The inspection of six unused pads received from the consumer found no defects or anomalies.

• Brand Name: POISE PADS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ
• Type of Device: GARMENT, PROTECTIVE, FOR INCONTINENCE
• Manufacturer (Section D): NEENAH COLD SPRING FACILITY; 1050 cold spring road; neenah WI 54956
• Manufacturer (Section G): NEENAH COLD SPRING FACILITY; 1050 cold spring road; neenah WI 54956
• Manufacturer Contact: emily arnould, rn bsn ; 2100 winchester rd; neenah, WI 54956 ; 9207213128
• MDR Report Key: 15019722
• MDR Text Key: 295953930
• Report Number: 2184163-2022-00001
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NONE
• 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: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MODERATE
• Device Lot Number: LF207627X0440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2022
• 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): Hospitalization
• Patient Age: 15 YR
• Patient Sex: Female
• Patient Weight: 41 KG