MAUDE Adverse Event Report: GSK MEMPHIS FACILITY BLOCK DRUG POLIDENT DENTURE CLEANSER (UNKNOWN)

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Anaphylactoid (2218); Reaction (2414)

Event Type  No Answer Provided  

Event Description

Anaphylactic reaction (anaphylaxis).Case description: this case was reported by a nurse via call center representative and described the occurrence of anaphylaxis in a patient who received double salt denture cleanser (polident denture cleanser (unk) unknown for an unknown indication.On an unknown date, the patient started polident denture cleanser (unknown).On an unknown date, an unknown time after starting polident denture cleanser (unknown), the patient experienced anaphylaxis (serious criteria gsk medically significant).On an unknown date, the outcome of the anaphylaxis was recovered/resolved.It was not reported if the reporter considered the anaphylaxis to be related to polident denture cleanser (unk).This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.The patient used polident denture cleanser (unknown) and experienced anaphylactic reaction (seriousness: gsk medically significant) 4 years ago.

• Brand Name: POLIDENT DENTURE CLEANSER (UNKNOWN)
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): GSK MEMPHIS FACILITY BLOCK DRUG; memphis TN
• Manufacturer (Section G): GSK
• Manufacturer Contact: p.o box 13398 research triangle park; 8888255249
• MDR Report Key: 4473894
• MDR Text Key: 5563464
• Report Number: 1020379-2015-00001
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Type of Report: Initial
• Report Date: 01/23/2015

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: Other
• Initial Date Manufacturer Received: 01/23/2015
• Initial Date FDA Received: 01/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other