MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-19 for HY-TAPE manufactured by Hy-tape International, Inc..
[131324181]
I developed contact dermatitis from 2 different adhesive products used in the operating room during surgery. One was a tape (hy-tape) used to hold the et tube in place. I got a rash across my whole face below the nose. The other was from a monitor lead. Clear trace, used to defect nerve/muscle fasciculations during surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082358 |
| MDR Report Key | 8186218 |
| Date Received | 2018-12-19 |
| Date of Report | 2018-12-18 |
| Date of Event | 2018-12-15 |
| Date Added to Maude | 2018-12-20 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HY-TAPE |
| Generic Name | TAPE AND BANDAGE, ADHESIVE |
| Product Code | KGX |
| Date Received | 2018-12-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HY-TAPE INTERNATIONAL, INC. |
| Brand Name | CLEAR TRACE ELECTRODES |
| Generic Name | ELECTRODE, ELECTROSURGICAL |
| Product Code | JOS |
| Date Received | 2018-12-19 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2018-12-19 |