MAUDE Adverse Event Report: HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED BELIFU; STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF

Model Number SM9126

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 10/12/2019

Event Type  Injury  

Event Description

Skin burned by the tens electrodes!!!! i.We are reporting unlawful sales of medical products on the internet; the reported device being sold on (b)(6) does not meet the specifications in the 510 (k) premarket submission; the reported device is being sold on (b)(6) before the 510 (k) clearance is granted.The reported (b)(6) seller shenzhen huayan e-commerce co., ltd does not register their establishment on fda.Ii.Information about the seller, product, manufacturer which are being reported; product and seller¿s information on (b)(6).Product page link from (b)(6).Seller name on (b)(6), brand name: belifu.Seller¿s company name: shenzhen huayan e-commerce co., ltd.One primary id number from photos of product reviews? (b)(4)? please refer to the link of review: (b)(6); manufacturer¿s information from fda? https://www.Accessdata.Fda.Gov/scripts/cdrh/cfdocs/cfrl/rl.Cfm?start_search=1&showlist+1&establishmentname=®num=&statename=&countryname=®istrationnumber=3010402752&owneroperatornumber=&owneroperatorname=&productcode=&devicename=&propietaryname=&establishmenttype=&pagenum=10&sortcolumn=establishmentname20%25asc.Device foreign manufacturer: hong qiangxing (shen zhen) electronics limited 4f, (b)(4).Device foreign manufacturer registration number (dev#): (b)(4).Manufacturer¿s legal representative: (b)(4)- all 510 (k) numbers owned by the manufacturer: k 121719, k 133979, k 133108, k 183154, k 171821; product information from gudidi?https://accessgudid.Nlm.Nih.Gov/devices/00321911080500.Brand name: belifu.Version or model: tens.Primary di number: (b)(4).Fda premarket submission number: k121719.Company name: hong qiangxing (shen zhen) electronics limited; product specifications from 510 (k) summary: https://www.Accessdata.Fda,gov/cdrh_docs/pdf12/k 121719.Pdf.Iii.Evidences regarding the unlawful sales of medical products on the internet; (b)(6) seller shenzhen huayane e-commerce co., ltd have not registered facility on fda.All medical device establishments, such as manufacturers, distributors, repackagers and relabers, and foreign firms, are required to register their establishment and list their generic product with the fda.This requirement is applicable for all medical devices, even those devices that fall into a generic category of exempted class i devices or class ii 510 (k) premarket exempt devices; the reported device being sold on (b)(6) does not meet the specifications in the 510 (k) premarket submission.As you may see the product, which is selling now on (b)(6), is tested with 190?s max pulse width while the 510 (k) summary for k 121719 clearly state that the max pulse width is 100?s.In other words, the max pulse width for this product is almost twice than the limitation in k 121719 510(k) summary.Iv.Plan of action proposed; please check randomly on the seller¿s (b)(6) inventory to see whether the specifications of the products being sold are consistent with 510 (k) summary.Product page link from (b)(6).Ask (b)(6) for cooperation to check whether the seller belifu (shenzhen huayan e-commerce co., ltd) has already had facility registered on fda; fda team at us customs should investigate products and ask for recall for illegal products.The manufacturer uses (a) company name hong qiangxing electronics and product name mini massager and body massager to make customer clearance; please alert (b)(6) to suspend illegal product sales to keep american consumers safe.Fda safety report id # (b)(4).

• Brand Name: BELIFU
• Type of Device: STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
• Manufacturer (Section D): HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED
• MDR Report Key: 9694283
• MDR Text Key: 179406099
• Report Number: MW5092912
• Device Sequence Number: 1
• Product Code: GZJ
• UDI-Device Identifier: 00321911080036
• UDI-Public: (01)00321911080036
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SM9126
• Device Catalogue Number: TENS
• Device Lot Number: (32)191108(30)02025
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Weight: 70