MAUDE Adverse Event Report: ALLERGAN PLEASANTON UNK COOLTONE; DERMAL COOLING PACK/VACUUM/MASSAGER

Catalog Number UNK COOLTONE

Device Problems Smoking (1585); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/27/2022

Event Type  malfunction  

Manufacturer Narrative

Based on the information currently available, technical review, and laboratory inspection, although no adverse event was reported, there is the possibility of: skin irritation/ hypersensitivity and electric shock.A supplemental report will be submitted if and when additional information is obtained.

Event Description

Allergan aesthetics received a report of cooltone unit popping sound with smell of smoke and port b not working.No serious injury reported.

Manufacturer Narrative

H11: corrected data: upon further review of the reported event, there was no serious injury.

Event Description

Upon further review of the reported event, there was no serious injury.

• Brand Name: UNK COOLTONE
• Type of Device: DERMAL COOLING PACK/VACUUM/MASSAGER
• Manufacturer (Section D): ALLERGAN PLEASANTON; 4410 rosewood dr; pleasanton CA 94588
• Manufacturer (Section G): ZIMMER MEDIZINSYSTEME GMBH; junkersstrasse 9; neu-ulm
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; austin, TX 78727 ; 8479366324
• MDR Report Key: 15268853
• MDR Text Key: 301561818
• Report Number: 3007215625-2022-01255
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK COOLTONE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2022
• Initial Date FDA Received: 08/22/2022
• Supplement Dates Manufacturer Received: 11/10/2022
• Supplement Dates FDA Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: No
• 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