MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-03 for LATEX TOE SHIELD UNK manufactured by Liquid Rubber Appliance Laboratories, Inc..
[20192228]
Podiatrist reports that 3 or 4 of his pts in the last 1 1/2 yrs have had allergic reactions including localized itching, redness, and swelling after using latex toe shields. Dr's concern is that this may sensitize pts to latex and later head to anaphylactic reactions upon exposure to other latex products.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1010864 |
| MDR Report Key | 72457 |
| Date Received | 1997-03-03 |
| Date of Report | 1997-03-03 |
| Date Added to Maude | 1997-03-05 |
| 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 | LATEX TOE SHIELD |
| Generic Name | LATEX TOE SHIELD |
| Product Code | MNE |
| Date Received | 1997-03-03 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 72331 |
| Manufacturer | LIQUID RUBBER APPLIANCE LABORATORIES, INC. |
| Manufacturer Address | 45 VALLEY WAY WEST ORANGE NJ 07052 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-03-03 |