MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-29 for TRIA BEAUTY SRL 3426D manufactured by Tria Beauty.
[96126952]
(b)(6) /2017 - (b)(4) customer service, reached out to customer via email to state the customer is outside of money back guarantee, and to ask that if there are any concerns with the device than they would like to hear back from the customer. (b)(6) 2017 - (b)(4), tried to reach out to the customer again. (b)(6) 2017 - (b)(4) finally heard back from the customer. (b)(4) hear of "claims of stroke related to to the device" at this time. (b)(6) 2017 - cc (customer care) sent case to clinical on 12/05/2017. (b)(6) 2017 - initial contact email sent to request phone call.. (b)(6) 2017 - reply from customer stating they will ask husband tomorrow if call is possible/reply sent to customer to confirm contents of email. (b)(6) 2017 - email sent to customer to ask what time we can arrange phone call for later in day/ customer replied indicating "now"/called the customer but went straight to voicemail/ customer asked for (b)(4) number, which was sent to customer but then no call was ever received. (b)(6) 2017 - 2nd call attempt to customer in the day. Call went to voicemail. Could not leave message because voicemail box was full (b)(6) 2017 - email sent to customer with follow up questions and request for husband's medical records. (b)(6) 2017 - email sent to customer with request for phone call or email response with answers to questions from previous email. (b)(6) 2017 - call attempt to (b)(6) and left vm. (b)(6) 2017 - call attempt to (b)(6). Could not leave vm because the mailbox was full. (b)(6) 2017 - qa findings from (b)(4): "the device primarily used on level 1, our training level. Level 1 output was measured at 4. 71mj, which is within our acceptable range. There were no registered faults on the device. I did not see any sign of physical damage that would lead me to believe that the device had been compromised in any way. " (b)(6) 2017 - couple back and forth email exchanges with customer. Explanation of importance sent to customer to be able to get their clinical information/reply from customer with push back and also stating "no need for any follow up and complaint only for informational purposes so they can get their money back. " (b)(6) 2017 - (b)(6) called (b)(6) and spoke on the phone with store manager, (b)(6). (b)(6) stated that the device was received in their store via postal service on nov. 6, 2017 and that they reached out to (b)(6). At (b)(6) via email on (b)(6) to notify of the shipment they received. The device was shipped out of (b)(6) to (b)(6) in (b)(6) on nov. 8. (b)(6) reached out to (b)(6) at (b)(4) to reach out to the customer on (b)(6). It was learned from this conversation that (b)(6) had no contact with the customer, and the store was not sure why the customer had decided to to return the (b)(6) product to their store. Conclusion: customer's initial report claims husband, (b)(6), used the laser (purchased from (b)(6) on (b)(6) 2016) all over his face. According to the customer, the day after use of the laser, (b)(6) 2017, the customer's husband had a stroke. The customer claimed they believed the stroke was associated with the use of the adl. Multiple call and email attempts were made from (b)(6) to the customer to obtain information, but all were unsuccessful to get further clinical information and details of use of the device from the customer. The only information provided from the customer via email was the date of use of the laser. The customer returned the device to (b)(6). (reasons for the customer returning the device to (b)(6) are unclear, except that the customer was looking to get money back for the device. ) qa test findings revealed no fault in the device and the the device was primarily used on energy level 1, training level. In the most recent email from the customer, they stated that their initial complaint report was "for fyi" purposes, and there is "no need for any follow up. "
Patient Sequence No: 1, Text Type: N, H10
[96126953]
The customer ((b)(6)) returned an age-defying laser (adl) device back to (b)(6) while claiming her husband, (b)(6) used the device all over his face and forehead for the first time the day ((b)(6) 2017) before the stroke, and that they believed it was associated with the use of the adl. The customer was reluctant to provide any further information about her husband's conditions and confirming "no need to follow-up". Ultimately she wanted to obtain a refund for the device, which was out of warranty and refund period. (b)(6) obliged and provided the refund, while confirming the device was functioning properly without any defect.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005572989-2017-00001 |
| MDR Report Key | 7156086 |
| Date Received | 2017-12-29 |
| Date of Report | 2017-12-29 |
| Date of Event | 2017-03-14 |
| Date Facility Aware | 2017-12-05 |
| Date Mfgr Received | 2017-12-05 |
| Device Manufacturer Date | 2016-09-07 |
| Date Added to Maude | 2017-12-29 |
| 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. VINCE NGUYEN |
| Manufacturer Street | 7999 GATEWAY BLVD., SUITE 100 |
| Manufacturer City | NEWARK CA 94560 |
| Manufacturer Country | US |
| Manufacturer Postal | 94560 |
| Manufacturer Phone | 5103627999 |
| Manufacturer G1 | BENCHMARK ELECTRONICS THAILAND |
| Manufacturer Street | 94 MOO 1 HITECH INDUSTRIAL EST BANLANE, BANGPA-IN |
| Manufacturer City | AYUTHAYA, THAILAND |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TRIA BEAUTY |
| Generic Name | AGE-DEFYING LASER (ADL) |
| Product Code | ONG |
| Date Received | 2017-12-29 |
| Returned To Mfg | 2017-12-07 |
| Model Number | SRL |
| Catalog Number | 3426D |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRIA BEAUTY |
| Manufacturer Address | 7999 GATEWAY BLVVD., SUITE 100 NEWARK CA 94560 US 94560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-29 |