MAUDE Adverse Event Report: CYNOSURE LLC TEMPSURE

Catalog Number 100-7027-010

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

Patient Problems Erythema (1840); Pain (1994)

Event Date 03/07/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced pain and redness on the face following a tempsure treatment.

Manufacturer Narrative

A device evaluation was performed and there was no indication of device malfunction.The device history record confirms that the product passed and met all requirements before releasing.During a follow up post treatment, site physician diagnosed the patient with shingles manifesting on the left side of the face.Patient was given acyclovir for preventative medication.The event is reportable since the patient was diagnosed with shingles.

• Brand Name: TEMPSURE
• Type of Device: TEMPSURE
• Manufacturer (Section D): CYNOSURE LLC; 5 carlisle road; westford MA 01886
• Manufacturer Contact: kelli pennie ; 5 carlisle road; westford, MA 01886 ; 9783672425
• MDR Report Key: 14110724
• MDR Text Key: 289251947
• Report Number: 1222993-2022-00016
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 0084149410764
• UDI-Public: (01)0084149410764(11)210119
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 100-7027-010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2022
• Initial Date FDA Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2021
• 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 Sex: Female