MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-03-10 for CUSHION GRIP manufactured by .
[5483990]
This spontaneous report originating from the united states as received from a consumer's daughter refers to a female pt of unk age. This report concerns 1 pt and 1 device. On an unk date, the pt started therapy with polyvinyl acetate (cushion grip) for an unk indication. No other co-suspects were reported. No concomitant medications were reported. On an unk date the pt experienced congestive heart failure and was in the hosp. No treatment info was reported. The action taken on the product was unk. The outcome of the event was unk. The pt's congestive heart failure was considered to be unk to the polyvinyl acetate (cushion grip). The polyvinyl acetate (cushion grip) was not available for the investigation. For the polyvinyl acetate (cushion grip), the lot number was not available and the serial number was not available. Additional info was not expected.
Patient Sequence No: 1, Text Type: D, B5
[13051858]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210048-2015-00001 |
| MDR Report Key | 4589037 |
| Report Source | 04 |
| Date Received | 2015-03-10 |
| Date of Report | 2015-02-25 |
| Date Mfgr Received | 2015-02-25 |
| Date Added to Maude | 2015-03-12 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | PO BOX 4 |
| Manufacturer City | WEST POINT PA 194860004 |
| Manufacturer Country | US |
| Manufacturer Postal | 194860004 |
| Manufacturer Phone | 2156527905 |
| Manufacturer G1 | MSD CONSUMER CARE INC |
| Manufacturer Street | 4207 MICHIGAN AVE RD NE |
| Manufacturer City | CLEVELAND TN 37323 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37323 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSHION GRIP |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOP |
| Date Received | 2015-03-10 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2015-03-10 |