MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-10-07 for COREGA SIN SABOR manufactured by Glaxosmithkline Dungarvan Ltd.
[29722167]
Exacerbation of symptoms (gastritis) [corrosive gastritis]. Pain in the ear [ear pain]. Overdose [overdose]. Accidental ingestion [accidental ingestion of product]. Case description: this case was reported by a consumer via call center representative and described the occurrence of corrosive gastritis in a (b)(6) female patient who received double salt dental adhesive cream (corega sin sabor) cream for product used for unknown indication. Concomitant products included pantoprazole and ranitidine. On an unknown date, the patient started corega sin sabor. On an unknown date, an unknown time after starting corega sin sabor, the patient experienced corrosive gastritis (serious criteria gsk medically significant), ear pain, overdose and accidental ingestion of product. On an unknown date, the outcome of the corrosive gastritis, ear pain, overdose and accidental ingestion of product were unknown. It was unknown if the reporter considered the corrosive gastritis and ear pain to be related to corega sin sabor. Additional information, this case was reported by a consumer. She informed she had been using corega cream sin sabor for more than 1 year and recently she had been performing excess use of the product since their lower prosthesis was not adjusted. She was accidentally ingesting this product and then according to the rest of an endoscopy the mild gastritis had became antral erosive gastritis chronic. She also had presented ear pain. Follow up information was received on 23 september 2015. The call center contacted the reporter who provided further information about the case such as patient demographic data and concomitant treatments. The physician informed that the ear pain was related to the fact that the prosthesis was inadequate and not to corega use. She used aluminum hydroxide every time she ingested the product. The action taken of device corega sin sabor was no change.
Patient Sequence No: 1, Text Type: D, B5
[34088482]
This case was reported by a consumer via call center representative and described the occurrence of corrosive gastritis in a (b)(6) female patient who received double salt dental adhesive cream (corega sin sabor) cream for product used for unknown indication. Concomitant products included pantoprazole and ranitidine. On an unknown date, the patient started corega sin sabor. On an unknown date, an unknown time after starting corega sin sabor, the patient experienced corrosive gastritis (serious criteria gsk medically significant), ear pain, overdose and accidental ingestion of product. On an unknown date, the outcome of the corrosive gastritis, ear pain, overdose and accidental ingestion of product were unknown. It was unknown if the reporter considered the corrosive gastritis and ear pain to be related to corega sin sabor. Additional information, this case was reported by a consumer. She informed she had been using corega cream sin sabor for more than 1 year and recently she had been performing excess use of the product since their lower prosthesis was not adjusted. She was accidentally ingesting this product and then according to the result of an endoscopy the mild gastritis had became antral erosive gastritis chronic. She also had presented ear pain. Follow up information was received on 23 september 2015. The call center contacted the reporter who provided further information about the case such as patient demographic data and concomitant treatments. The physician informed that the ear pain was related to the fact that the prosthesis was inadequate and not to corega use. She used aluminum hydroxide every time she ingested the product. The action taken of device corega sin sabor was no change. Follow up details was received on 18 november 2015. The physician had informed that the patient was very nervous and agitated. The physician had informed that patient used antidepressant medication (was not specified) and confirmed that patient used drug pump inhibitor (was not specified). The physician had also informed that when the patient was medicated she stayed well. The physician did not know if corega sin sabor was related to the events presented. The physician did not had more information and must contact others patients health care professional like maxillofacial and otolaryngologist to obtain more information. Action taken for concomitant medication pantoprazole 40 mg and ranitidine was updated to no change (dechallenge and rechallenge was not applicable). The reported causality of pain in the ear was updated to no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003721894-2015-00013 |
| MDR Report Key | 5168143 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-10-07 |
| Date of Report | 2015-09-22 |
| Date Mfgr Received | 2015-11-18 |
| Date Added to Maude | 2015-10-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | PO BOX 13398 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 8888255249 |
| Manufacturer G1 | GSK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COREGA SIN SABOR |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOL |
| Date Received | 2015-10-07 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLAXOSMITHKLINE DUNGARVAN LTD |
| Manufacturer Address | DUNGARVAN, WATERFORD EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-07 |