MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-26 for SIT AND DECOMPRESS BELT manufactured by .
[71181444]
I ordered a belt from (b)(6) which claimed to relieve back pain. They said they had "medical" evidence. The unit did not help and caused pain in areas i did not have pain before. I paid (b)(6) for it plus (b)(6) shipping. Then another (b)(6) to exchange for a bigger size because they told me to get the wrong size. Then another (b)(6) to return it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068702 |
| MDR Report Key | 6439211 |
| Date Received | 2017-03-26 |
| Date of Report | 2017-03-26 |
| Date of Event | 2017-03-22 |
| Date Added to Maude | 2017-03-28 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| 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 | 0 |
| Brand Name | SIT AND DECOMPRESS BELT |
| Generic Name | SIT AND DECOMPRESS BELT |
| Product Code | ILZ |
| Date Received | 2017-03-26 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-03-26 |