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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNEVA MEDICAL, INC. ARTEFILL DERMAL FILLER; IMPLANT, DERMAL, FOR AESTHETIC USE
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SUNEVA MEDICAL, INC. ARTEFILL DERMAL FILLER; IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Model Number AF0508 (SUSPECTED)
Device Problems Off-Label Use (1494); Insufficient Information (3190)
Patient Problems Reaction (2414); Patient Problem/Medical Problem (2688)
Event Date 11/01/2013
Event Type  Injury  
Manufacturer Narrative
Patient reports that she became "severely ill" about 3 weeks after artefill dermal filler injection in (b)(6) 2013 and was hospitalized at that time.She states that the cause of the illness was not found.However, the patient also states she is allergic to "bovine" and she believes it may have been a possible allergic reaction to the product which contains bovine collagen.She also states that the required 4 week skin test was not done prior to the injections.The patient states she: is allergic to bovine.Had a mini-lift done on the same day as the injections in (b)(6) 2013 by the same doctor who injected artefill in the nasolabial folds (on-label) and possibly also a little bit in the lips (contraindicated for artefill) has breast implants which she is planning on having removed.Has autoimmune symptoms; however relays there is no diagnosis of any autoimmune issues and her doctor does not believe there is any relation to the artefill injections that she had in 2013.Gets sick when she eats.Patient will not provide the name of the injector at this time.She doesn't want the doctor contacted by suneva medical until she gets her medical records.No further contact with the patient at this time after additional attempts to see if suneva medical can contact the injector.
 
Event Description
Patient reports that she became "severely ill" about 3 weeks after artefill dermal filler injection in (b)(6) 2013 and was hospitalized at that time.She states that the cause of the illness was not found.However, the patient also states she is allergic to "bovine" and she believes it may have been a possible allergic reaction to the product which contains bovine collagen.She also states that the required 4 week skin test was not done prior to the injections.
 
Manufacturer Narrative
Patient reports that she became "severely ill" about 3 weeks after artefill dermal filler injection in (b)(6) 2013 and was hospitalized at that time.She states that the cause of the illness was not found.However, the patient also states she is allergic to "bovine" and she believes it may have been a possible allergic reaction to the product which contains bovine collagen.She also states that the required 4 week skin test was not done prior to the injections.The patient states she: is allergic to bovine.Had a mini-lift done on the same day as the injections in (b)(6) 2013 by the same doctor who injected artefill in the nasolabial folds (on-label) and possibly also a little bit in the lips (contraindicated for artefill).Has breast implants which she is planning on having removed.Has autoimmune symptoms; however relays there is no diagnosis of any autoimmune issues and her doctor does not believe there is any relation to the artefill injections that she had in 2013.Gets sick when she eats.Patient will not provide the name of the injector at this time.She doesn't want the doctor contacted by suneva medical until she gets her medical records.No further contact with the patient at this time after additional attempts to see if suneva medical can contact the injector.Follow up #1, dated 12/04/2018 - additional and new information: subsequent to the emdr submission the patient provided permission to speak with her injector and provided his contact information, dr.(b)(6) of (b)(6).Per dr.(b)(6), there are no apparent physical issues with this patient and is normal upon exam.He states the patient's complaints regarding autoimmune symptoms are vague, non-specific, and appear to be psychosomatic.An autoimmune workup came back non-conclusive.Regarding the patient's report of hospitalization 3 weeks after her artefill injections and her statement that she is allergic to bovine, the doctor relays that an additional skin test (which contains bovine collagen) was conducted after her injections and it was negative.He states that he may re-test based on the patient's statement that she has an allergy to bovine; however he reports on 11/02/2018 that the patient has not returned.He states that he will reach out to the patient and will call suneva if he has anything new to report.The lot numbers used in the patient's procedure remain unknown.The doctor states that the patient's records have been archived and he requests that suneva search shipping history to determine potential lots.Suneva determined potential lots based on customer shipping history and conducted lot reviews.All potential lots were manufactured according to approved work instructions and met all acceptance criteria upon release.All potential lots have since expired; therefore retained lot samples are not available for review.Section d6: updated implantation date to (b)(6) 2013 per injector provided information.Section g7: this is follow-up #1.
 
Event Description
Patient reports that she became "severely ill" about 3 weeks after artefill dermal filler injection in (b)(6) 2013 and was hospitalized at that time.She states that the cause of the illness was not found.However, the patient also states she is allergic to "bovine" and she believes it may have been a possible allergic reaction to the product which contains bovine collagen.She also states that the required 4 week skin test was not done prior to the injections.
 
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Brand Name
ARTEFILL DERMAL FILLER
Type of Device
IMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
SUNEVA MEDICAL, INC.
5870 pacific center blvd.
san diego CA 92121
MDR Report Key7807991
MDR Text Key117960264
Report Number3003707320-2018-00015
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P020012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 08/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberAF0508 (SUSPECTED)
Device Catalogue NumberAF0508 (SUSPECTED)
Was Device Available for Evaluation? No
Date Manufacturer Received07/23/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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