MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-05 for INTENSITY DI4738 manufactured by Shenzhen Dongdixin Technology Co, Ltd..
[135150018]
An insurance company called (b)(4), (b)(6) 2019. The insurance company defending a case regarding a intensity if combo device, di4738 - they requested assistance proving this device cannot cause atrial fibrillation in a patient. They are attempting to prove the physical therapist using this device was negligent in using it. The insurance company called to see if anyone in our company can dispute causation & is looking for someone to testify and defend that the device cannot cause atrial fibrillation in a patient. No alleged product problem is being reported at this time (as mentioned above, the insurance company is attempting to prove the physical therapist using this device was negligent in using it). No further details regarding the user's condition before or regarding this alleged event available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2019-00004 |
| MDR Report Key | 8308514 |
| Date Received | 2019-02-05 |
| Date of Report | 2019-02-05 |
| Date of Event | 2019-01-11 |
| Date Facility Aware | 2019-01-11 |
| Report Date | 2019-02-05 |
| Date Reported to FDA | 2019-02-05 |
| Date Reported to Mfgr | 2019-02-05 |
| Date Added to Maude | 2019-02-05 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 3 |
| Brand Name | INTENSITY |
| Generic Name | TENS UNIT |
| Product Code | GZJ |
| Date Received | 2019-02-05 |
| Model Number | DI4738 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
| Manufacturer Address | NO. 3 BUILDING XILIBAIMANG XUS INDUSTRIAL ESTATE NANSHAN SHENZHEN GUANGDONG, 518108 CH 518108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-05 |