MAUDE Adverse Event Report: GLAZOSMITHKLINE CONSUMER HEALTHCARE, L.P. POLYGRIP; ADHESIVE, DENTURE, CARBOXYMETHYLCELLULOSE SODIUM (32%) AND ETHYLENE-OXIDE HOMOPO

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

Patient Problems Pain (1994); Unspecified Eye / Vision Problem (4471); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/25/2019

Event Type  Injury  

Event Description

"used at (b)(6) 2019; (b)(4)".On (b)(6) 2019 at 11:10 am called polygrip 1-866-640-1017, case (b)(4), 888-825-5249 fda; customer service 1-888-463-6332; on (b)(6) 2019 at 2:45 pm talked to (b)(4) at 800-930-5450.(b)(6), i was told it would be (b)(6) to get it analyzed to see what it had to make me so sick.Was told that i needed a lawyer.On (b)(6) 2019 called poly grip 1-866-640-1017.Case # (b)(4), gave them phone number, and the tube of poly grip which was "w r 3 w." on (b)(6) 2019 called them back and was told at 10:35am not to call back and if they needed me they would call me, and that i would not be charged for this phone call.On (b)(6) 2019 at 4:15 pm i talked to (b)(4) and i asked him when i could expect the forms that they said they would send me to fill out, and he said it takes time for them to get it altogether.On (b)(6) 2020 received the form to fill out.Sent consent and submitted form (b)(6) 2020.I can't afford an attorney, so i am going to ask the public to help me and i can't afford to get it checked out and to see what is in it that make my "wrists hunt," and my vision has gotten so bad.I want to know if it is what has caused me to go to a pain specialist to get injections in my back, i am also getting my right breast removed or it might be just a lumpectomy.I won't know for sure until (b)(6) 2020 when i have my surgery.

• Brand Name: POLYGRIP
• Type of Device: ADHESIVE, DENTURE, CARBOXYMETHYLCELLULOSE SODIUM (32%) AND ETHYLENE-OXIDE HOMOPO
• Manufacturer (Section D): GLAZOSMITHKLINE CONSUMER HEALTHCARE, L.P.
• MDR Report Key: 14471130
• MDR Text Key: 292840408
• Report Number: MW5109830
• Device Sequence Number: 1
• Product Code: KOL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 80 KG