MAUDE Adverse Event Report: CONSUMER SERVICES KIMBERLY-CLARK CORPORATION POISE THIN-SHAPE PADS #5

Device Problems Device Emits Odor (1425); Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2017

Event Type  No Answer Provided  

Event Description

Poise thin-shape pads regular length #5 absorbancy.I have used poise pad of one kind or another for years.Since (b)(6) (estimate), i have been purchasing these pads that, when wet, smell just terrible, like burning rubber.I thought something was wrong with me.I tried changing my diet and reduced all my medications to no avail.I then tried a different brand.No smell! so i phoned the number on the package and told them.I believe that was in (b)(6).I returned 2 packages to (b)(4) telling them they were defective and had a terrible odor when wet.The company sent a refund after taking down all the info.I stopped using them until i had to purchase them in (b)(6), when our local store only had those.No bad smell, so i bought some more at (b)(4) this week.They smelled even worse than i remembered.I went back to our local store.Again, they only had poise in what i needed, so i got them thinking they had been ok, but this time, they smelled badly, too! now i have a pack from both stores that smell terrible.I just think someone should find out why and just how safe any of these products are.I do not remember exact dates.(b)(6) through now.Regular length numbers on 3 pks that are bad.I only have 2 from 2 stores, do not know where these numbers go (b)(4).Product type: personal protection.Thin-shaped pads #5 aqua colored bag.Manufacturer address: (b)(4).Manufacturer phone number: (b)(4).Retailer: (b)(4).Retailer state: (b)(4).Purchase date: (b)(6) 2017.This date is an estimate.I still have the product in my possession: yes.The product was damaged before the incident: no.The product was modified before the incident: no.Once i knew it was this product, i contacted them in (b)(6) 2017.May we release your name and contact information: yes, you may release my name and contact information to the product manufacturer/importer/private labeler.Report number: (b)(4).

• Brand Name: POISE THIN-SHAPE PADS #5
• Type of Device: POISE THIN-SHAPE PADS #5
• Manufacturer (Section D): CONSUMER SERVICES KIMBERLY-CLARK CORPORATION
• MDR Report Key: 7095546
• MDR Text Key: 94483892
• Report Number: MW5073794
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1