MAUDE Adverse Event Report: STRATA SKIN SCIENCES XTRAC VELOCITY 400; EXCIMER LASER

Model Number V400

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

Patient Problem Missing Value Reason (3192)

Event Date 01/07/2017

Event Type  Injury  

Manufacturer Narrative

Strata skin sciences clinical representative ((b)(6)) has scheduled a training visit to the customer.

Event Description

On 01/12/2017 was reported to strata skin sciences inc, by the mother's patient that her daughter was treated at dr.'s (b)(6) on (b)(6) 2017 around 9:20 am, as a result of the treatment she was severely burned; she was given rx and stated that she should not be co-paying for this.Also stated that the technician did not know what she was doing.Strata skin sciences clinical representative ((b)(6)) called the patient's mother on 01/17/2017 to obtain further information and to verify the patient's well-being but no response.A message was left to call back.Strata skin sciences technical representative ((b)(6)) was dispatched to dr.(b)(6) office to verify the device condition.The device was found operating within specifications.Strata skin sciences clinical representative ((b)(6)) called for the second time the patient's mother on 01/23/2017 to obtain further information and to verify the patient's well-being but no response.A message was left to call back.Strata skin sciences sales representative (bob) visited dr.(b)(6) office on 02/02/2017 to obtain further information.There is a new dr.Working part time at the office that performed the treatment but had not been trained by strata skin sciences.

• Brand Name: XTRAC VELOCITY 400
• Type of Device: EXCIMER LASER
• Manufacturer (Section D): STRATA SKIN SCIENCES; 2375 camino vida roble b; carlsbad CA 92011
• Manufacturer (Section G): STRATA SKIN SCIENCES; 2375 camino vida roble b; carlsbad CA 92011
• Manufacturer Contact: moe abushaban ; 2375 camino vida roble b; carlsbad, CA 92011
• MDR Report Key: 6946088
• MDR Text Key: 89282603
• Report Number: 2031934-2017-00001
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: V400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention