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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC EVOLENCE COLLAGEN FILLER IMPLANT, DERMAL, FOR AESTHETIC USE

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JOHNSON & JOHNSON CONSUMER INC EVOLENCE COLLAGEN FILLER IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Model Number NOTAPPLICABLE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Discomfort (2330); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment, not diagnosis. Patient weight and ethnicity were not available for reporting. This report is for one (1) evolence collagen filler unspecified usa. Lot # and udi # are not available. Device is not expected to be returned for manufacturer review/investigation. Device evaluation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Device history records review could not be completed without lot number. At this time, with limited information provided, this event is being reported with an overabundance of caution. The manufacturing for this product ceased in 2009 and the pma was delisted per fda correspondence dated 20-dec-2010. This closes out this report unless other additional significant information is received. The product is indicated for the correction of moderate to deep facial wrinkles and folds such as nasolabial folds and should not be implanted in spaces other than the dermis of the face. The safety and effectiveness of evolence has not been established for the treatment of anatomic regions other than facial wrinkles and nasolabial folds such as peri-ocular area as described in this case. (b)(4) if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
This case was received from a (b)(6) female consumer who received an unspecified dose of evolence under the eye upon the recommendation of a cosmetic surgeon for unspecified indication approximately 13 or 14 years ago. After a few years, the consumer noted that the product did not dissolve and she has lines under her eye. She also reported that the area swells when she has seasonal allergies. She consulted a physician who recommended surgical removal but there is no information on any diagnostics done and the diagnosis. There is no available information on the dose, indication for use, progression of the condition and the medical history.
 
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Brand NameEVOLENCE COLLAGEN FILLER
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
JOHNSON & JOHNSON CONSUMER INC
199 grandview rd
skillman NJ 08558 9418
Manufacturer (Section G)
COLBAR LIFESCIENCE, LTD
116 derech gad fineshtein
pob 2105
rehovot NJ
Manufacturer Contact
laurie rauco
199 grandview rd
skillman, NJ 08558-9418
2152734905
MDR Report Key12391312
MDR Text Key268912286
Report Number2214133-2021-00038
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
070013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNOTAPPLICABLE
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Other
Date Manufacturer Received02/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes

Patient Treatment Data
Date Received: 08/31/2021 Patient Sequence Number: 1
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