MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,company representative, report with the FDA on 2015-06-05 for ULTRA COREGA CREMA SIN SABOR manufactured by Glaxosmithkline Dungarvan Ltd.
[5866469]
Prosthesis is loose [device issue], feels the lip and gum slobbery [oral disorder]. Case description: this case was reported by a consumer via call center representative and described the occurrence of device issue in a (b)(6) female patient who received gsk denture adhesive (formulation unk) (ultra corega crema sin sabor) unk (batch number v54d, expiry date 10/30/2017) for product used for unknown indication. On an unknown date, the patient started ultra corega crema sin sabor. On an unknown date, an unknown time after starting ultra corega crema sin sabor, the patient experienced device issue (serious criteria gsk medically significant) and oral disorder. On an unknown date, the outcome of the device issue and oral disorder were unknown. It was unknown if the reporter considered the oral disorder to be related to ultra corega crema sin sabor.
Patient Sequence No: 1, Text Type: D, B5
[75478208]
Description off white to beige mass of gums and petrolatum, free of lumps, granular particles or foreign matter. Result: complies ph 6. 5-7. 5. Result 6. 7. % gantrez 25. 5%-34. 5%. Result: 28. 1%. Testing was carried out on the retain sample and results were within specification indicating that the product was satisfactory for use. The batch documentation was checked before release and on receipt of this complaint and found to be satisfactory. Follow up information received on august 21, 2015. Testing was carried out on the retain sample and results were within specification indicated that the product was satisfactory for use. The batch documentation was checked before release and on receipt of this complaint and found to be satisfactory. The product complaint was unsubstantiated. The product complaint reference id was 200070731. The event assessment for device issue was changed from not applicable to unknown. The action taken with the device was unk. See scanned page.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681138-2015-00017 |
| MDR Report Key | 4862958 |
| Report Source | 01,04,COMPANY REPRESENTATIVE, |
| Date Received | 2015-06-05 |
| Date of Report | 2015-05-27 |
| Date Mfgr Received | 2015-05-27 |
| Date Added to Maude | 2015-06-24 |
| 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 | ULTRA COREGA CREMA SIN SABOR |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOL |
| Date Received | 2015-06-05 |
| Lot Number | V54D |
| Device Expiration Date | 2017-10-30 |
| 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; 2. Deathisabilit | 2015-06-05 |