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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Purulent Discharge (1812); Edema (1820); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Discomfort (2330); No Code Available (3191)
Event Date 07/31/2019
Event Type  Injury  
Manufacturer Narrative
Manufacturer narrative: no potential quality issues have been identified in the manufacturing process of the specified batch. The batch is manufactured and released according to galderma quality management system. Pharmacovigilance comment: the serious event of infection and abscess at the implant site were considered expected and possibly related to the treatments. Serious criteria included hospitalization and the need for extended medical and surgical interventions with antibiotics and drainages to prevent permanent damage. The non-serious events of nodule, oedema, induration, inflammation and pain at the implant site, and injection site discomfort, injection site scab and purulent discharge were considered expected and possibly related to the treatments. Potential contributory factors include injection procedure or concomitant unspecified treatment received during the same period. The case meets the criteria for expedited reporting to the regulatory authorities. Capa comment: 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.
Event Description
Case reference number (b)(4) is a spontaneous report sent on 29-aug-2019 by a non health professional, which refers to a (b)(6)-year-old female patient. The patient is living in (b)(6) for 4 months but on vacation in (b)(6). The patient's medical history included app (pulmonary alveolar proteinosis) during childhood and the patient is a tobacco user, 5-10 cigarettes per day. The patient had no allergies. On (b)(6) 2019, the patient received treatment with 2 ml restylane skinbooster vital lidocaine (lot 16905-1, expiry date 31-dec-2020) to face (1 ml on each side) with intradermal 29 g needle and unknown injection technique for skin rejuvenation. The patient also received treatment with restylane to tear troughs (unknown lot number, amount, needle type and injection technique). On (b)(6) 2019, the patient noticed the appearance of two nodules (implant site nodule) on the level of the face, with progressively edema (implant site oedema) of the whole of the face and the upper lip. It was reported that the patient took 1000mg of augmentin from (b)(6) 2019 to (b)(6) 2019. On (b)(6) 2019, the patient experienced an infection (implant site infection) and cutaneous abscesses (implant site abscess) on right and left jaw and nasolabial area. The patient was hospitalized and no more details were provided. During this period from the day of treatment until the occurrence of the adverse event, the patient had undergone another treatment in (b)(6). Additional information regarding the treatment in (b)(6) has been requested, as that treatment might be also the reason for the adverse event. On (b)(6) 2019, the patient was undergoing treatment with augmentin [amoxicillin][clavulanic acid] until (b)(6) 2019, with subsequent increase of oedema, spontaneous drainage of some nodules with pus (purulent discharge) and appearance of new nodules. Last antibiotic therapy before this episode of amoxicillin clavulanate was for a pilonidal cyst. No dental intervention before the appearance of lesions. On (b)(6) 2019, the patient visited the emergency room and was put on treatment with ciprofloxacin or ceftriaxone [ceftriaxone] 2gm iv until (b)(6) 2019 (discrepancy: both drugs were reported from different sources). From (b)(6) 2019, the patient received omnicef [cefdinir] 300mg 2x per day orally and local fucidin [fusidic acid] until (b)(6) 2019. The local status and especially the edema improved but the patient noticed the appearance of new nodules, the last two days ((b)(6)). The patient was also hospitalized due to the infection, however no date has been provided (most likely during the days she received the iv treatments). The patient had been in (b)(6) for a few days on planned trips, and needed to go to (b)(6) on saturday for 1 week before returning to (b)(6). On (b)(6) 2019, the patient was reviewed and the status was deep induration (implant site induration) of right nasal fold without change of skin. At left side, an inflammatory paranasal nodule, indurated, non-fluctuating, painful (implant site pain), 2 nodules at nasogenian area including a scabby (injection site scab), nodular cluster opposite the horizontal branch of the mandible, with fluctuation. The mandibular nodules were punctured with extraction of 4ml of pus and sent to bacteriology. The patient was put on an antibiotic window and mri was scheduled. On (b)(6) 2019, the patient underwent an mri of the whole face. The results showed a mass of 8mm on the right mandible located in the dermis. The mass was accompanied by an important edema of the dermis, extending to the skin and the surface of the left mandible. The edema extended posteriorly to the anterior part of the masseter muscle, as well as along the maxillary right maxilla. The well-defined signal anomalies, located in front of the left maxillary sinus, nodulary, with a discrete inflammatory reaction evokes the deposition of hyaluronic acid. The edema extends to the floor of the left orbit. On the left side, there was evidence of a nodule in the dermis, measuring 8. 6 mm, accompanied by an edema located in the soft, less prominent than the left side, extending upwards, facing the upper left maxillary, facing the floor of the orbit accompanied by a discrete edema, without mass effect, evoking the place of injection of hyaluronic acid. A second nodular lesion, 3. 4mm presented on the left side, with a discreet liquid content, and wall on the right side, estimated at 2. 8 mm, slightly irregular. In comparison with the left masseter muscle, in the dermis, there exists a third lesion of the same semiology as that described above, of smaller size, measuring 4. 4 mm. On (b)(6) 2019, the patient had a follow-up (post-mri) consultation. The patient seems relieved at the left mandibular level where the physician punctured 4 ml of purulent fluid. The bacteriological result is always negative for any germ. However, it presented an increasing pain in the left suborbital and tension (injection site discomfort) in the right cheek. The mri showed the persistence of a 0. 9 mm collection at the level of the horizontal branch of the left mandible with an inflammatory tissue(implant site inflammation) around the perimeter. Similarly, a left suborbital mass but on the radio it does not present a collection. However, the mass at the level of the right cheek presents an important induration with in the middle a fluid collection of mm. The physician recommended that after this puncture an antibiotic will be started that will be adapted to the antibiotic therapy. In order to evaluate the possibility of an intra-oral evacuation and to avoid scars that the patient would not like, an intra-oral incision is proposed at the right cheek and direct incision on sub. Orbital level and at mandibular angle. However, according to the advice of infectious diseases and since the patient does not present a systematic symptom with absence of fever, it is proposed to perform this gesture at 48h. Therefore, the patient was reviewed a maxillofacial surgery for abscess evacuation and introduction of adequate antibiotic therapy. On (b)(6) 2019, the patient bought bepanthen (dexpanthenol) 5%. On (b)(6) 2019, the patient was prescribed mouthwash with chlorhexidine 10ml (three times daily); chlorhexidine/benzoxonium disinfecting solution; dressing. On (b)(6) 2019, the patient had a follow-up consultation. The abscesses were drained on the (b)(6) 2019 and the patient resumed with the treatment of bactrim forte [trimethoprim][sulfamethoxazole] 160mg 1 capsule three times per day, as discussed after drainage. The samples did not reveal any germ, in particular no staphylococcus aureus (samples taken after a 48-hour antibiotic window, but patient was under antibiotic treatment between (b)(6) 2019 to (b)(6) 2019. Cultures for mycobacteria were still in progress. The patient was evolving favorably. The patient was instructed to continue antibiotic therapy with trimethoprim sulfamethoxazole 800 / 160mg 1 capsule, three times per day, for a total of two weeks, ie for another 10 days. A clinical follow-up of control was scheduled in 10 days in her country of residence. We discussed with the patient about her treatment and advised her to avoid touching her face with her hands. On (b)(6) 2019, an esthetic physician in (b)(6) instructed the patient to perform facial lymphatic draining twice weekly for one month, associated with slight massages of the indured areas. On (b)(6) 2019, the patient e-mailed her physician in (b)(6) and requested a final conclusion that indicated the probable cause of her infection. She mentioned that the culture sampling should have been performed before the antibiotic therapy had started. She also requested the results from the second sampling performed on (b)(6) 2019 as she was scheduled for a follow-up at a clinic on (b)(6) 2019. On (b)(6) 2019, the physician replied the patient and sent the medical records he had. Also, the physician suggested that the patient continued with her antibiotics until (b)(6) 2019 and thereafter be reassessed. The physician, rechecked the files again and still did not find anything like bacteria aside from the bacteria in the mouth, that was probably due to contamination during intraoral sampling. On (b)(6) 2019, the patient received an e-mail from the infectious disease specialist. He also stated that at the level of bacteriology, there were no germs detected. This was probably the result of antibiotic therapy already administered before the sampling. If the evolution was rather favorable, he agreed to stop the antibiotic treatment as planned, on (b)(6) 2019. There was still a culture underway for the research of atypical germs (atypical mycobacteria, which sometimes can take 4-5 weeks to grow). This culture has been requested to cover all the possibilities, but, in view of the favorable clinical evolution and staphylococcus-like presence on stainings, there was no real concern for a mycobacterial infection. On (b)(6) 2019, the patient replied the specialist, that she will stop the antibiotic therapy on (b)(6). She also stated that she hoped the small, hard mass that still persisted in the eye and on the mandible would go away since. Her dermatologist had advised her to do lymphatic drainage. Outcome at the time of the report: infection was recovering/resolving. Cutaneous abscesses was recovering/resolving. Nodules was not recovered/not resolved. Edema was recovering/resolving. Pus was recovered/resolved. Induration was recovering/resolving. Scabby was recovering/resolving. Painful was recovering/resolving. Tension was recovering/resolving. Inflammatory tissue was recovering/resolving.
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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 Key9215434
MDR Text Key176267485
Report Number9710154-2019-00096
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeQA
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2019
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: 10/21/2019 Patient Sequence Number: 1