MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-12-17 for TRUE UNK manufactured by Glaxo Wellcome, Inc..
[17170350]
Rptr administered a patchtest to pt in 7/98 for thimerosal sensitivity. Her reaction was positive and she continued to react. She was last seen on 11/11/98 with localized itching, redness and swelling. She has been treated with topical steroids to no avail and is being referred to another dermatologist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1015241 |
| MDR Report Key | 202397 |
| Date Received | 1998-12-17 |
| Date of Report | 1998-12-17 |
| Date of Event | 1998-07-01 |
| Date Added to Maude | 1998-12-21 |
| 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 | TRUE |
| Generic Name | THIMERASOL PATCH TEST |
| Product Code | DHB |
| Date Received | 1998-12-17 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 196593 |
| Manufacturer | GLAXO WELLCOME, INC. |
| Manufacturer Address | 1011 N ARENDELL AVE. ZEBULON NC 27597 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-12-17 |