MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-10-17 for QUATTRO 2.5 DQ8450 manufactured by Shenzhen Dongdixin Technology Co., Ltd..
[89457890]
The device history record was examined for the subject device. There were no problems observed during the manufacturing or testing noted in the dhr. The device labeling was reviewed and found to be suitable and adequate for the device to perform its intended use. The operator didn't use the electrodes which is recommended by manufacturer. The most likely reason that caused burns is that user didn't follow the instructions in the user manual to clean the skin surface over which electrodes are placed. Or the long-term use of electrode pads, cause pads are so dirty that impedance is not uniform.
Patient Sequence No: 1, Text Type: N, H10
[89457951]
An end-user received second degree burns from treatment with use of a quattro 2. 5 tens unit. The user was diagnosed by a doctor at urgent care. The chiropractor's technician used the doctor's (chiropractor's) travel card (instructions on where to place the electrodes per patient) to apply 4 electrodes to the patient's (end-user's) upper back. This patient advised the technician (this is a repeat patient who had not seen this particular technician before) her skin doesn't always take well to the electrodes; i. E. , other technicians had previously - at times - had a problem getting the electrodes to stick well. The technician removed the electrodes from the bag and felt they were sticky. This set of electrodes was opened in (b)(6) 2016, and this is the third use of this set of electrodes for the patient. The office does not share electrodes amongst patients. The electrodes were placed on the patient's upper back with a 2- finger width distance apart from one another. The intensity was slowly increased to 26, and the patient acknowledged that this was a good intensity. The patient was then seated in a traction massage chair with heat applied to her neck area, but not over the electrodes. The technician left the patient to help with another. When she looked back at the patient, she noticed a look of discomfort on her face. The technician questioned if she was ok and the patient said she was feeling the intensity very strong and asked the technician to turn down the intensity. The output intensity was decreased to a point where the patient was more comfortable (we do not know the level to which it was decreased). The treatment was then completed. As the technician removed the electrodes, she noted a larger white spot and two smaller white spots. She walked the patient to the front of the office and asked a more experienced technician to review the markings. The technician believed these markings were burns. When the patient left the office, she was ok, but later followed up at an urgent care center. She was diagnosed with second degree burns. The doctor from urgent case advised the burns would probably take 4 weeks to heal and provided the patient with an ointment for the burns. She was advised to keep the area clean and dry. Additional use information subsequent to the initial complaint include the following: confirmation that, again, no heat was applied over the electrodes; the electrodes used were 4 2"x2" durastick plus, 1/5" apart, their third use on this patient; the device is confirmed as having been turned off when the pads were removed or adjusted; it is confirmed that the electrodes were not placed on open wounds, rashes or swollen, red, infected or inflamed areas or skin eruptions; there is confirmed experience with the used waveform prior to using this device (chiropractor technician); the electrodes were stored in the bag they came in, sealed and stored in a drawer in a cabinet; the user manual is confirmed as having been read in regards to electrode placement; the device was less than 6 months in use, and new lead wires were not tried; the lead wires are also confirmed as having no exposed wires or damage. The customer had stated that the "waveform on the device was a little dirty. " the device was returned to compass health brands on (b)(4) 2016 - some observations of the returned device include the following: the housing on the unit did not have any visible damage, no leads or cables were sent back with the device, the lcd screen functioned properly, the channel and ac port metal pin(s) were in place without any visible corrosion, its warranty seal was not broken and the serial number of the returned device matched the one listed in the case ((b)(4)). All four channels were tested and fell within spec range. The unit was tested with compass health quality lead wires, as no leads or cables were sent back from the customer. Overall, compass health brands was unable to duplicate the customer's complaint, and could not find a product defect present.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005170249-2017-00003 |
| MDR Report Key | 6953916 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-10-17 |
| Date of Report | 2016-03-23 |
| Date of Event | 2016-02-26 |
| Date Mfgr Received | 2016-03-23 |
| Device Manufacturer Date | 2014-12-16 |
| Date Added to Maude | 2017-10-17 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| 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 | QUATTRO 2.5 |
| Generic Name | TENS UNIT |
| Product Code | GZJ |
| Date Received | 2017-10-17 |
| Model Number | DQ8450 |
| 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 | 2017-10-17 |