MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-03-13 for CUSHION GRIP manufactured by Schering Corp..
[5464270]
Event verbatim: cancer. Case description: this spontaneous reported originating from the united states as rec'd from a consumer's wife refers to a male pt of unk age. This reported concerns one pt and one device. This pt used the 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 was diagnosed with cancer (medically significant). No treatment info was reported. The action taken and the outcome were unk. The reporter considered the pt being diagnosed with cancer to be not related to the polyvinyl acetate (cushion grip). The polyvinyl acetate (cushion grip) was not available for investigation. For the polyvinyl acetate (cushion grip), the lot number was not available and the serial number was available. Add'l info was not expected.
Patient Sequence No: 1, Text Type: D, B5
[13006303]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210048-2015-00002 |
| MDR Report Key | 4605172 |
| Report Source | 04 |
| Date Received | 2015-03-13 |
| Date of Report | 2015-03-06 |
| Date Mfgr Received | 2015-03-06 |
| Date Added to Maude | 2015-03-17 |
| 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 G1 | MSD CONSUMER CARE INC |
| Manufacturer Street | 4207 MICHIGAN AVENUE 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 | 2015-03-13 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SCHERING CORP. |
| Manufacturer Address | 2000 GALLOPING HILL RD. KENILWORTH NJ 07033053 US 07033 0530 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-03-13 |