MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-10-30 for TOF-GUARD manufactured by Organon Teknika Corporation.
[19159]
Skin under proximal electrode of peripheral nerve stimulator left volar surface upper extremity at the wrist had minor injury secondary to the device several small petechiae noted. She had undergone ulnar nerve stimulator intermittently for 28 hrs, monitoring the degree of neuromuscular blockade by the study drug.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1007491 |
| MDR Report Key | 27544 |
| Date Received | 1995-10-30 |
| Date Added to Maude | 1995-10-31 |
| 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 | TOF-GUARD |
| Generic Name | PERIPHERAL NERVE STIMULATOR |
| Product Code | GZI |
| Date Received | 1995-10-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 28456 |
| Manufacturer | ORGANON TEKNIKA CORPORATION |
| Manufacturer Address | DURHAM NC 27704 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-10-30 |