MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-03 for EXTRA HEAVY GREEN RUBBER DAM manufactured by Hygenic Corp..
[9812]
Allergic reaction/contact dermatitis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000171 |
| MDR Report Key | 11390 |
| Date Received | 1994-02-03 |
| Date of Report | 1993-07-12 |
| Date of Event | 1993-06-15 |
| Date Added to Maude | 1994-02-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXTRA HEAVY GREEN RUBBER DAM |
| Product Code | EIE |
| Date Received | 1994-02-03 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 11390 |
| Manufacturer | HYGENIC CORP. |
| Manufacturer Address | AKRON OH 44310 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-02-03 |