MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-01-03 for NEW POLIGRIP SA manufactured by Glaxosmithkline Dungarvan Ltd.
[183290767]
Argus case id (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[183290768]
Anaphylactic shock [anaphylactic shock], blister [bullae]. Case description: this case was reported by a consumer via licensee and described the occurrence of anaphylactic shock in a (b)(6) female patient who received double salt dental adhesive cream (new poligrip sa) cream for denture wearer. Concurrent medical conditions included denture wearer. On an unknown date, the patient started new poligrip sa. On an unknown date, an unknown time after starting new poligrip sa, the patient experienced anaphylactic shock (serious criteria hospitalization and gsk medically significant) and bullae (serious criteria hospitalization). On an unknown date, the outcome of the anaphylactic shock and bullae were recovered/resolved. It was unknown if the reporter considered the anaphylactic shock and bullae to be related to new poligrip sa. [clinical course]: the patient, the reporter's mother, experienced anaphylactic shock (seriousness: gsk medically significant and hospitalization) by using new poligrip sa. She developed blisters (seriousness: hospitalization) on her arm(s), neck, and back after using new poligrip sa. She was hospitalized for one day. On an unknown date, the symptom was resolved after she discontinued using new poligrip sa. The physical abnormality (anaphylactic shock) and bullae on the arm(s), neck, and back were resolved. [reporter's comment]: (opinion by the physician) the physician was not sure what did not agree with the patient since the details on the ingredients of the drug were unknown until he/she asked the manufacturer. No further information is expected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003721894-2019-00376 |
| MDR Report Key | 9544911 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2020-01-03 |
| Date of Report | 2019-12-06 |
| Date Mfgr Received | 2019-12-06 |
| Date Added to Maude | 2020-01-03 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEW POLIGRIP SA |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOT |
| Date Received | 2020-01-03 |
| Device Availability | * |
| 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. Hospitalization; 2. Other | 2020-01-03 |