MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-09-22 for CUSHION GRIP manufactured by .
[20293618]
Case description: this spontaneous report originating from the united states was received from a consumer and refers to a male pt of an unk age. 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 a "series strokes" (medically significant). The pt also reported that the product had become hard. No treatment info was reported. The outcomes of the pt's "series of strokes" and the product becoming hard were unk. The action taken with the product was unk. The reporter considered his "series of strokes" and the product becoming hard to be not related to polyvinyl acetate (cushion grip). The polyvinyl acetate (cushion grip) was not available for investigation. For polyvinyl acetate (cushion grip), the lot number was albj16, the expiration date and the serial number were not available. Additional info is not expected. Update (b)(6) 2014: lot number albj16 was verified as a valid lot number for polyvinyl acetate (cushion grip).
Patient Sequence No: 1, Text Type: D, B5
[20495890]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210048-2014-00001 |
| MDR Report Key | 4121446 |
| Report Source | 04 |
| Date Received | 2014-09-22 |
| Date of Report | 2014-09-16 |
| Date Mfgr Received | 2014-09-16 |
| Date Added to Maude | 2014-12-05 |
| 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 | P.O. 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 | 2014-09-22 |
| Lot Number | ALBJ16 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-09-22 |