MAUDE Adverse Event Report: GLAXOSMITHKLINE SUPER POLIGRIP (UNSPECIFIED ZINC FREE VARIANT); DOUBLE SALT DENTAL ADHESIVE CREAM

Device Problems Material Disintegration (1177); Improper or Incorrect Procedure or Method (2017)

Patient Problems Toxicity (2333); Numbness (2415)

Event Type  Other  

Event Description

This case was reported by a consumer and described the occurrence of zinc poisoning in a female pt who received double salt dental adhesive cream (super poligrip (unspecified zinc free variant)) cream for dentures.A physician or other health care professional has not verified this report.On an unk date, the pt started double salt dental adhesive cream (dental).At an unk time after starting double salt dental adhesive cream, the pt experienced zinc poisoning, hand and feet numbness, device misuse and product complaint.The pt stated, "when they tested everyone for zinc poisoning, we (my husband and myself) tested positive." she reported that her hands and feet are numb.She stated that and sees a tube of poligrip in 3 days (product misuse).She reported a product complaint as poligrip dissolves like magic when she eats anything hot or chocolate.This case was assessed as medically serious by (b)(6).Treatment with double salt dental adhesive cream was continued.At the time of reporting, the outcome of the events was unk.This (b)(4) is linked to case (b)(4) (same reporter).The manufacturer's report number for this case is 9681138-2014-00002.Super poligrip is manufactured in (b)(4), and neither the product nor lot number for this product is available.(b)(4).

• Brand Name: SUPER POLIGRIP (UNSPECIFIED ZINC FREE VARIANT)
• Type of Device: DOUBLE SALT DENTAL ADHESIVE CREAM
• Manufacturer (Section D): GLAXOSMITHKLINE; research triangle park NC 27709
• Manufacturer (Section G): GLAXOSMITHKLINE, IRELAND, CLOCHERANE; youghal rd.; dungarvan ; EI
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 3660764
• MDR Text Key: 16058263
• Report Number: 9681138-2014-00002
• Device Sequence Number: 1
• Product Code: KOL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2014
• 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
• Treatment: UNSPECIFIED MEDICATIONS (UNK - UNK)
• Patient Outcome(s): Other