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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COREGA ADHESIVE STRIPS; DENTURE ADHESIVE

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COREGA ADHESIVE STRIPS; DENTURE ADHESIVE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Ischemia (1942)
Event Type  Injury  
Manufacturer Narrative
Argus case (b)(4).
 
Event Description
Aneurysm; mesenteric ischemia; case description: this case was reported by a dentist via sales rep and described the occurrence of aneurysm in a (b)(6) year-old female patient who received polyethylene oxide, sodium carboxymethylcellulose (corega adhesive strips) strip for drug use for unknown indication.On an unknown date, the patient started corega adhesive strips.On an unknown date, an unknown time after starting corega adhesive strips, the patient experienced aneurysm and mesenteric ischemia (serious criteria gsk medically significant).On an unknown date, the outcome of the aneurysm and mesenteric ischemia were unknown.It was unknown if the reporter considered the aneurysm and mesenteric ischemia to be related to corega adhesive strips.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: the patients suffered aneurysm and mesenteric ischemia and they believe that these are related to the use of adhesive corega.Action taken with corega was withdrawn with dechallenge unknown.This case was linked to (b)(4).
 
Event Description
Case description: this case was reported by a dentist via sales rep and described the occurrence of aneurysm in a 80-year-old female patient who received polyethylene oxide, sodium carboxymethylcellulose (corega adhesive strips) strip for drug use for unknown indication.On an unknown date, the patient started corega adhesive strips.On an unknown date, an unknown time after starting corega adhesive strips, the patient experienced aneurysm and mesenteric ischemia (serious criteria gsk medically significant).On an unknown date, the outcome of the aneurysm and mesenteric ischemia were unknown.It was unknown if the reporter considered the aneurysm and mesenteric ischemia to be related to corega adhesive strips.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: the patients suffered aneurysm and mesenteric ischemia and they believe that these are related to the use of adhesive corega.Action taken with corega was withdrawn with dechallenge unknown.This case was linked to (b)(4).This report is being resubmitted to capture corrections.The information was received on 06 jun 2019 and is as follows: the suspect product name was changed to ultra corega cream.Comment: downgrade report.
 
Manufacturer Narrative
Argus case id (b)(4).The suspect product changed, see section "5.Describe event or problem" for details.
 
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Brand Name
COREGA ADHESIVE STRIPS
Type of Device
DENTURE ADHESIVE
MDR Report Key8707703
MDR Text Key148334252
Report Number3004699328-2019-00010
Device Sequence Number1
Product Code KOL
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 06/06/2019
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
Initial Date Manufacturer Received 06/06/2019
Initial Date FDA Received06/18/2019
Supplement Dates Manufacturer Received06/06/2019
Supplement Dates FDA Received07/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age80 YR
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