MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-10-22 for NEUROTIP * NT540SCA000 manufactured by Owen Mumford, Ltd..
[295075]
Neurotip was being used to assess lower limb sensation. Pt returned to clinic half an hour later experiencing the beginning of an allergic reaction. Mfr was contacted by the healthcare professional in charge who was advised of the material quantities that make up the content of the steel. It was then mentioned by co's 'new product design manager' that nickel could be the offending material. It was noted that the pt has many allergies and is not known to have a specific allergy to nickel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8021764-2003-00004 |
| MDR Report Key | 491367 |
| Report Source | 05 |
| Date Received | 2003-10-22 |
| Date of Report | 2003-10-22 |
| Date of Event | 2003-08-13 |
| Date Mfgr Received | 2003-09-29 |
| Device Manufacturer Date | 2003-02-01 |
| Date Added to Maude | 2003-10-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CHRIS FREER, CORPORATE |
| Manufacturer Street | BROOK HILL |
| Manufacturer City | WOODSTOCK, OXON OX201TU |
| Manufacturer Country | * |
| Manufacturer Postal | OX20 1TU |
| Manufacturer Phone | 93812021 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROTIP |
| Generic Name | NEUROLOGICAL EXAMINATION PIN |
| Product Code | GXB |
| Date Received | 2003-10-22 |
| Model Number | * |
| Catalog Number | NT540SCA000 |
| Lot Number | N0097 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 480072 |
| Manufacturer | OWEN MUMFORD, LTD. |
| Manufacturer Address | BROOK HILL WOODSTOCK, OXON UK OX20 ITU |
| Baseline Brand Name | NEUROTIP |
| Baseline Generic Name | NEUROLOGICAL EXAMINATION PIN |
| Baseline Model No | * |
| Baseline Catalog No | NT540SCA000 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-10-22 |