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Lot Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Cellulitis (1768); Unspecified Infection (1930); Inflammation (1932); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Scarring (2061); Swelling (2091); Discomfort (2330); Patient Problem/Medical Problem (2688); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Pharmacovigilance comments: the serious, expected events of implant site scar and implant site nodule, and the unexpected event of deformity were considered possibly related to the treatment. Serious criteria included important medical events that have led to potential permanent damage to a body structure. The non-serious, expected events of implant site pain, implant site swelling, implant site infection, implant site abscess, implant site cellulitis, inflammation, nerve injury and discomfort, and the unexpected events of neuralgia and skin tightness were considered possibly related to the treatment. Potential etiologies and contributory factors include previous treatment and removal of a permanent filler, and subsequent fat cell transfer in the affected area. The case meets the criteria for expedited reporting to the regulatory authorities. Engineering evaluation: the information in this single case does not suggest involvement of a nonconforming product or quality problem and will not initiate a corrective or preventive action. Manufacturing narrative: lot number was not reported. (b)(4).
Event Description
Case reference number (b)(4) is a spontaneous report sent on 23-oct-2014 by a male consumer, which refers to himself (unknown age). No information about medical history, concomitant medication or history of allergies. The patient was treated with sculptra for many years before the treatment in (b)(6) 2012 without experiencing any issues. It was reported that the patient was first treated with sculptra in 2005 for an unknown indication and the patient stated that at that time it was a common issue to develop small lumps under the skin, which were not visible. As a result of this the patient chose to use another product, bio-alcamid (permanent filler), which was in his face for a couple of years until it was removed. Facial fillers where no longer an option for the patient, who decided to undergo fat cell transfer, which apparently worked well but this was a treatment that required time until gradual results occurred. Unfortunately, the patient stated that his treatment plan was "seriously messed up" by the hospital involved, which resulted in being referred back to the sculptra/newfill product. In (b)(6) 2012, the patient received treatment with sculptra to face (unknown lot number, amount, needle type and injection technique) at (b)(6) hospital in (b)(6). Several days post treatment in (b)(6) 2012, the patient developed three very painful(implant site pain) large lumps/nodule (implant site nodule) on the right cheek. In addition to this, the patient also experienced disfigurement (deformity), quite disfiguring features. In particular at the patient's left cheek an irregular ridge developed which totally distorted his features. The patient returned to the hospital and saw the person who injected him, where at which stage she informed him that the lumps in his cheek were nodules and that they could be removed but not by them. That was the last time the patient saw the operator. The patient further reported that it took around a month for the swelling (implant site swelling) to subside but the horrendous lumps where still left in his cheek. In (b)(6) 2012, the patient's left under eye area started to swell really badly. It was like a rubbery, thick, inflamed tyre around his eye, which looked like a swollen eye bag after receiving a punch in the face. The patient called the treating hospital and was told it was not life threatening, and they were not obliged to do anything about it. No more contact with the hospital was performed. Subsequent to the sculptra treatment, the patient had developed significant disfigurement and multiple facial infections (implant site infection). Some, very serious, and mostly where the nodules "where", in his right cheek for years before the infections. Around this time, the patient also experienced severe neuralgia (neuralgia) and inflammation (inflammation) around the right cranial and scalp regions. It was horrendous for at least three years post sculptra injury. The patient also reported that when the abscess (implant site abscess) and cellulitis (implant site cellulitis) formed on his face, it took a whole year to reduce and begin to heal. The patient had considerable tightness (skin tightness) around both cheeks, as well as stiffness and pulling in his left eye where there today remains a large nodule. There is also still significant irregularity and disfigurement through both sides of his face. There is some kind of fibrous ridgy material above left temple and ear. The patient reported that obviously there was still material in his face, as ultrasound had shown. The ultrasound results were not provided. The patient also reports he has nerve damage (nerve injury) in various parts of his face. The most damage is at his left cheek and eye area that was also where a lot of the discomfort (discomfort) is occurring. Additionally, the patient stated that he was injected by relatively unskilled doctors, whom he thought certainly contributed to the disfigurement and the product under his eye that had caused permanent considerable scarring (implant site scar) and will require an extremely good surgeon to get it even close to looking improved. The patient provided some pictures of his face at present and since the last treatment with sculptra. It would appear that the product was injected close to his periorbital area causing significant problems under his eye. There was also a ridge that was extremely unsightly around the right cheek, and also at the left cheek to some degree. This had formed a lump in the center of the right cheek. It looked worse in some lights. Treatment for the adverse events was not reported. Outcome at the time of the report: disfigurement was not recovered/not resolved. Considerable scarring was not recovered/not resolved. Lumps/nodule was not recovered/not resolved. Painful was not recovered/not resolved. Swelling was unknown. Inflammation was unknown. Multiple facial infections was recovered/resolved. Neuralgia was unknown. Abscess was recovered/resolved. Cellulitis was recovered/resolved. Tightness was not recovered/not resolved. Nerve damage was not recovered/not resolved. Discomfort was not recovered/not resolved. Tracking list: v. 0 initial report sent to company medical information call center via e-mail (reference (b)(4)). V. 1 fu information was reported to (b)(4) (reference (b)(4)) on 28-oct-2014 and forwarded to (b)(4) on 29-oct-2014. V. 2 fu information was reported by the patient to (b)(4) on 12-nov-2018: updated the treatment date and outcome. Added 10 new events. Added serious criteria of permanent damage. This is a legacy case (b)(4), from (b)(4), who handled version 0 and 1 of this case. Version 2 of this case is the first submission performed by (b)(4), current manufacturer.
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Manufacturer (Section D)
seminariegatan 21
uppsala, SE-75 2 28
SW SE-752 28
Manufacturer (Section G)
seminariegatan 21
uppsala, SE-75 2 28
SW SE-752 28
Manufacturer Contact
amy poteate
14501 north freeway
fort worth, TX 76177
MDR Report Key8150276
MDR Text Key129891453
Report Number9710154-2018-00082
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial
Report Date 12/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/12/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/11/2018 Patient Sequence Number: 1