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

Model Number LONG

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

Patient Problem Abscess (1690)

Event Date 08/29/2016

Event Type  malfunction  

Manufacturer Narrative

A document and records review was performed on the reported lot.Documentation assessed includes: manufacturing, quality audit, production, raw material and device history records.This assessment found no anomalies that may have attributed to the reported issue; therefore the complaint could not be confirmed.The cause of the reported complaint could not be determined.Information from this incident will be included in our product complaint and mdr trend analysis.This was sent to test webtrader on (b)(6) 2016 the original submission date, and this is a resubmission to production.

Event Description

Consumer stated that she was seen at the emergency room for an abscess of the vulva.She said that it was drained and packed.She then followed up with her doctor and a second abscess was drained in his office.She has had two follow-up visits to the doctor due to packing removal.She was given two prescriptions, metronidazole 500 mg tablets three times a day and ciprofloxacn 500 every 12 hours to be taken every 12 hours.Consumer states she has greatly improved.

Manufacturer Narrative

Corrections: state, province, territory - incorrect state of (b)(6).Should be (b)(6).

• Brand Name: POISE PADS
• Type of Device: GARMENT, PROTECTIVE, FOR INCONTINENCE
• Manufacturer (Section D): NEENAH COLD SPRING FACILITY; 1050 cold spring road; neenah WI 54956
• Manufacturer (Section G): KIMBERLY CLARK- CORPORATION; 1050 cold spring road; neenah AR 54956
• Manufacturer Contact: jean nielsen ; 2100 winchester rd.; neenah, WI 54956 ; 5013366325
• MDR Report Key: 6034627
• MDR Text Key: 57681089
• Report Number: 2184163-2016-00002
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LONG
• Device Lot Number: LF617221X2241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2016
• 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: 65 YR