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

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.

• Brand Name: EVOLENCE COLLAGEN FILLER
• Type of Device: IMPLANT, 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 Key: 12391312
• MDR Text Key: 268912286
• Report Number: 2214133-2021-00038
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 070013
• Number of Events Reported: 1
• 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 Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: NOTAPPLICABLE
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 02/03/2022
• 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