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 QUATTRO 2.5 DQ8450 manufactured by Shenzhen Dongdixin Technology Co., Ltd..
[89572426]
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 most likely reason that caused burns is that the overuse of electrode and impedance of the electrode is not uniform.
Patient Sequence No: 1, Text Type: N, H10
[89572427]
The end-user was burned while receiving treatment from an electrotherapy device. The end-user had initially contacted their distributor to complaint about the electrodes. The clinic initially reported and complained (to compass health brands) about poor electrode quality, stating a patient had been burned while using them - during their report, it was learned that the end-user was also using a compass health brands' electrotherapy device. The office manager (of the clinic) had stated that this patient had been treated approximately 10 times previously without any issues. On (b)(6) 2017, the patient was treated by his physical therapist - four electrodes were placed on the patient's left cervical, right cervical, left cervicothoracic and right cervicothoracic region(s) for 15 minutes, confirming not directly on the bone. Amplitude was 5-15 hz continuous with 100% scan. During therapy, the patient told the physical therapist he was feeling some burning/shocking. The physical therapist lowered the device in intensity, and the patient agreed the lower intensity felt better. Upon removal of the electrodes, the physical therapist noticed a red, rashy area. He did not mention this to the patient. However, the patient returned approximately 30-45 minutes later, stating the area of treatment was really hurting, and asked that it be looked at. The office manager viewed the area and, in her words, it appeared "scorched. " he was seen by a doctor - his statement follows: "patient had redness on the right trap. There is a scab formation and red blistering along the pad placement site. Patient said he felt stinging and shocking at the area of placement. I explained to the patient the importance of keeping the area clean and disinfected. I placed neomycin on the area of the involvement, and placed a sterile gauze pad over it. He is to see another doctor friday morning or appoint sooner if the condition worsens. " this doctor states he had been in business for 23+ years, and has never had a patient burned. Per the office manager, in hindsight, they feel the electrodes "look different. " the difference they noted is that what they ordered (from another supplier) had only one wire into the electrodes, whereas what they received had 3, which is compass health brands' typical tree branch type electrode. The device involved in this event was returned to compass health brands for further evaluation on 3/7/2017. Compass health quality was unable to confirm the initial complaint - the device was tested for product performance, and determined to fall within the manufacturer's specifications, as define in the product's user manual; no defect or surge was detected. The electrodes sent back indicated to be used during the event - they were in a heavily-used condition; hair was present on the adhesive and had poor contact on the clear plastic film.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005170249-2017-00009 |
| MDR Report Key | 6957433 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-10-18 |
| Date of Report | 2017-03-09 |
| Date of Event | 2017-02-08 |
| Date Mfgr Received | 2017-03-10 |
| Device Manufacturer Date | 2014-03-24 |
| 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 | QUATTRO 2.5 |
| Generic Name | ELECTROTHERAPY DEVICE |
| Product Code | GZJ |
| Date Received | 2017-10-18 |
| Model Number | DQ8450 |
| Operator | PHYSICAL THERAPIST |
| 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 |