MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-10-18 for ACCURELIEF ACRL-9000 manufactured by Shenzhen Dongdixin Technology Co., Ltd..
[89566322]
The design history file was examined for the subject device. These devices are designed according to relevant safety standards and passed all compliance tests. The most likely reason that caused burns is that impedance of the electrode used by user is not uniform.
Patient Sequence No: 1, Text Type: N, H10
[89566323]
The end-user called reporting a one week-old burn. The end-user underwent a double mastectomy, and decided to have a tummy tuck at the same time. She had a small bulge on her abdomen, and her doctor recommended the tens unit to reduce the scar tissue. The user put the tens unit on for thirty minutes, using separate pads, one on the right side of the belly button, and one on the left - one hour later, she put the pads in the same area, and used the device for another thirty minutes. Pad "a" was ok, but pad "b" caused a second-degree burn the size of a quarter. Pad "b" is reported as having less silicone. The end-user is reported as having sought after/received medical attention for the burns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005170249-2017-00011 |
| MDR Report Key | 6957384 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-10-18 |
| Date of Report | 2017-07-13 |
| Date of Event | 2017-06-12 |
| Date Mfgr Received | 2017-07-14 |
| Date Added to Maude | 2017-10-18 |
| 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 | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR KANG JIANPING |
| Manufacturer Street | BLOCK A, 5TH FLOOR, FUHUA TECH NO. 9116 BEIHUAN ROAD |
| Manufacturer City | SHENZHEN, GUANGDONG 518108 |
| Manufacturer Country | CH |
| Manufacturer Postal | 518108 |
| Manufacturer G1 | SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. |
| Manufacturer Street | NO.3 BUILDING XILIBAIMANG XUSH INDUSTRIAL ESTATE,518108 |
| Manufacturer City | SHENZHEN, GUANGDONG 518108 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 518108 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCURELIEF |
| Generic Name | ELECTROTHERAPY DEVICE |
| Product Code | GZJ |
| Date Received | 2017-10-18 |
| Model Number | ACRL-9000 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. |
| Manufacturer Address | NO.3 BUILDING XILIBAIMANG XUSH INDUSTRIAL ESTATE,518108 SHENZHEN, GUANGDONG 518108 CH 518108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-18 |