MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-03-10 for MAGSTEPS MEDIUM SIZE 7-12 NI 2001 manufactured by Nikken, Inc..
[159961]
Add'l info received 9/23/99: pt spoke to his physician on 4/9/96. Pt has metarsalgia which is a very rare condition. The balls of pt's feet is skin and bones; the tissue is very thin skin. Because of this, his bare skin came in contact with the magnet event though he had socks on. "it is like going into your blood stream. " because the magnetic rays penetrated his skin and bones, "almost like cutting skin open and putting a magnet on it. " according to pt that is why he suffered an adverse reaction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1013127 |
| MDR Report Key | 154960 |
| Date Received | 1998-03-10 |
| Date of Report | 1998-03-10 |
| Date of Event | 1997-10-16 |
| Date Added to Maude | 1998-03-11 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | MAGSTEPS MEDIUM SIZE 7-12 |
| Generic Name | MAGNETIC SHOE INSERTS |
| Product Code | KYS |
| Date Received | 1998-03-10 |
| Model Number | NI |
| Catalog Number | 2001 |
| Lot Number | NI |
| ID Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 150941 |
| Manufacturer | NIKKEN, INC. |
| Manufacturer Address | 15363 BARRANCA PKWY. IRVINE CA 926182216 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-03-10 |