MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2015-09-22 for POLIGRIP manufactured by Glaxosmithkline Dungarvan Ltd.
[26966893]
No sample was returned for this complaint and also the day-code detail was not received as a full investigation could not be completed. As this information is not available the complaint cannot be substantiated. All of the documentation pertinent to a specific lot of finished product is contained in a 'batch envelope'. Prior to the disposition of the product, the contents of each batch envelope is reviewed and approved by the site quality department to verify that there were no significant quality issues recorded during manufacturing, packaging or testing. This review also verifies that all test results meet specification requirements. Please be assured that this complaint has been logged, will be indicated in the manufacturing site metrics and all be brought to the attention of all relevant site personnel as part of the monthly complaint review process.
Patient Sequence No: 1, Text Type: N, H10
[26966894]
Bleeding [hemorrhage]. Product complaint [product complaint]. Case description: this case was reported by a consumer via call center representative and described the occurrence of hemorrhage in a patient who received double salt dental adhesive cream, tocopherol acetate (poligrip) unknown for product used for unknown indication. On an unknown date, the patient started poligrip. On an unknown date, an unknown time after starting poligrip, the patient experienced hemorrhage (serious criteria gsk medically significant) and product complaint. On an unknown date, the outcome of the hemorrhage and product complaint were not reported. It was unknown if the reporter considered the hemorrhage to be related to poligrip. Additional information, the initial case was received on (b)(6) 2015. The consumer was complained that the unspecified poligrip was not sticking and that hoped it was only a temporary bleed implying patient had suffered bleeding also. The action taken was unknown. The product complaint number was unknown. Qa report received on (b)(6) 2015: qa results revealed the complaint to be unsubstantiated as no complaint sample had been received and the batch review indicated that all tests met specification requirements.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003721894-2015-00007 |
| MDR Report Key | 5108101 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2015-09-22 |
| Date of Report | 2015-08-05 |
| Date Mfgr Received | 2015-08-24 |
| Date Added to Maude | 2015-09-28 |
| 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 | POLIGRIP |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOL |
| Date Received | 2015-09-22 |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-09-22 |