MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-01-29 for STIM PLUS ELECTRONIC ACCUPUNCTURE STIM PLUS SW 1030 BODY CHECK MADE IN CHINA manufactured by Stim Plus Lms Enterprises.
[273968]
Faulty unit connection openings defective. Unit shorts out, telephone does not stay put in openings, falls out. Can cause electrocution. Should be recalled and taken off the market. Lms stim plus unit connections faulty and dangerous. Telephone cord and pin falls out of unit. Can cause serious damage to pacemakers. Can cause serious problems in person with heart problems. Lms stim plus refuses to send pt brand new unit in a-1 working condition.
Patient Sequence No: 1, Text Type: D, B5
[15035329]
Unit malfunctions by shorting out. User can see that the cylinder is off center and doesn't accomodate the pin on the wire. Has called distributor and they will send user a replacement device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1027388 |
| MDR Report Key | 440258 |
| Date Received | 2003-01-29 |
| Date of Report | 2003-01-29 |
| Date of Event | 2002-11-01 |
| Date Added to Maude | 2003-01-31 |
| 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 |
| 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 | STIM PLUS ELECTRONIC ACCUPUNCTURE |
| Generic Name | TO TREAT PAIN AND ARTHRITIS ETC |
| Product Code | BWK |
| Date Received | 2003-01-29 |
| Model Number | STIM PLUS SW 1030 BODY CHECK |
| Catalog Number | MADE IN CHINA |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 429196 |
| Manufacturer | STIM PLUS LMS ENTERPRISES |
| Manufacturer Address | PO BOX 941693 MAITLAND FL 32794 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2003-01-29 |