MAUDE Adverse Event Report: GALDERMA Q-MED RESTYLANE SILK; IMPLANT, DERMAL, FOR AESTHETIC USE (LMH)

Lot Number 13553

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cellulitis (1768); Cyst(s) (1800); Purulent Discharge (1812); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091); No Code Available (3191)

Event Date 04/12/2017

Event Type  Injury  

Manufacturer Narrative

Engineering evaluation: the events abscess, pain, induration, swelling and erythema were expected.Cellulitis, purulent discharge and implant site discharge were unexpected however the events are commonly associated with abscess/infections.Manufacturer narrative: a batch record review for lot 13553 did not reveal any deviations or other observations that indicate any product deficiencies.All chemical and microbiological test results were within the specification limits.Pharmacovigilance comment: the serious events of abscess at the implant site and non-serious events of pain, induration, swelling and erythema at the implant site were considered expected and possibly related to the treatment.The serious events cellulitis, purulent discharge and implant site discharge were unexpected and possibly related; however the events are commonly associated with abscess/infections.Potential contributory factors to the events include the injection procedure.This case meets the criteria for expedited reporting to regulatory authorities due to hospitalization and the surgical intervention.Distribution comment: this case meets the criteria for expedited reporting to regulatory authorities due to hospitalization and the surgical intervention.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 01-may-2017 and a follow-up on 04-may-2017 by a physician which refers to a female aged (b)(6).The patient's medical history and concomitant treatments were not reported.Allergies included sulfa and penicillin.The patient had not been previously received treatment hyaluronic acid fillers and received no other products at that time of the injections.On (b)(6) 2017, the patient was injected with 1 ml restylane silk (lot 13553) to bilateral tear trough, upper cheek, and left marionette lines and with 1 ml restylane defyne (lot 14768) to bilateral marionette lines with unknown needle and unknown technique.Approx 8 days later, on (b)(6) 2017, the patient experienced swelling(implant site swelling) and redness(implant site erythema) at cheek and marionette lines and pain/tender(implant site pain) at cheek.Approx 9 days later, on (b)(6) 2017, the patient contact the physician about the right cheek swelling.Instructed to use ice and do conservative management and seen in the office.Started on clindamycin [clindamycin] for presumptive cellulitis (implant site cellulitis), and 0.1cc of hyaluronidase [hyaluronidase] injected into right cheek.Approx 10 days later, on (b)(6) 2017, the patient calls office with increasing right cheek swelling and some of the left cheek as well.Started on medrol dose pack[methylprednisolone], with differential including delayed hypersensitivity versus cellulitis.Approx 11 days later, on (b)(6) 2017, patient swelling was decreased but now felt some firmer areas (implant site induration)of the cheeks.Approx 14 days later, on (b)(6) 2017, patient seen in office again and now left chin starting to drain (implant site discharge) spontaneously.Firmness of cheeks more discrete and under sterile conditions, 18 gauge needle aspiration was performed of both cheeks, obtaining serosanguinous fluid of the left cheek and pururlent/ pus like drainage(purulent discharge) material of the right cheek.Right cheek fluid sent for culture, and patient continued with clindamycin.Culture results preliminarily show wbc only, no organisms.Final culture results no growth.The patient experienced a small firm cystic area at cheeks; both cheeks had abscessed(implant site abscess).Approx 16 days later, on (b)(6) 2017, the patient experienced increased pain and swelling in her bilateral cheeks and her left marionette line.On that date the physician attempted to do a decompression using an 11 blade scalpel as corrective treatment, but was only able to do a partial decompression because the patient was very tender/discomfort.On the evening of (b)(6) 2017 the md took the patient to the operating room to do a full surgical decompression, incision and drainage (i&d) under anesthesia.Iv (intravenous) vancomycin [vancomycin] 1g given q12h, with one 1 dose given intra-operatively.Purulent material seen of both cheeks and l chin, all three sent for culture.Penrose drains left is all three areas.On (b)(6) 2017, left chin penrose drain had fallen out with nursing dressing change.All cultures still remained negative with only wbc seen, no organisms.Patient having diarrhea so all antibiotics were halted given all negative culture results.On (b)(6) 2017, all four cultures sent came back negative for growth and positive for wbcs only.Clindamycin was discontinued and the patient was discharged from the hospital.Approx 18 days later, on (b)(6) 2017, there was significant patient improvement and the patient was discharged to home with dressing changes and no antibiotics.Approx 21 days later, on (b)(6) 2017 the patient followed up with the physician and as of that date the outcome of the patient's swelling, pain, and redness was much improved.The patient only had minor redness around the drain insertion sites and was only mildly tender to palpation.The patient's abscessed areas/cystic areas were resolved.The drains of cheeks kept in as still some minor drainage.Patient was to follow up on (b)(6) 2017 for drain removal.On (b)(6) 2017, both cheeks stopped draining and drains were removed.Left chin started draining again presumably because initial drain was lost early, and incision and drainage performed in the office with drain placement.Treatment for the adverse event: on (b)(6) 2017:0.1ml of hyaluronidase in her right cheek and tear trough and was prescribed, clindamycin [clindamycin] as corrective treatment.On (b)(6) 2017: medrol dose pack.On 2017: aspiration of cheeks.Cultures sent.On 2017: partial decompression, full surgical decompression in hospital.Cultures were sent.Penrose drains placed, and 1 dose of intraoperative vancomycin.On (b)(6) 2017: cultures negative for growth and positive for wbcs only.Clindamycin discontinued.Patient discharged from hospital.On (b)(6) 2017: i&d of chin and drain inserted.Outcome at the time of the report: abscessed, pus like drainage was recovered/resolved.Redness, swelling, pain/tender was recovering/resolving.Drainage was not recovered.

Manufacturer Narrative

Engineering evaluation: the events abscess, delayed hypersensitivity, pain, induration, swelling and erythema were expected.Cellulitis, purulent discharge and implant site discharge were unexpected however the events are commonly associated with abscess/infections.Manufacturer narrative: a batch record review for lot 13553 did not reveal any deviations or other observations that indicate any product deficiencies.All chemical and microbiological test results were within the specification limits.Pharmacovigilance comment: the serious events of abscess and delayed hypersensitivity at the implant site and non-serious events of pain, induration, swelling and erythema at the implant site were considered expected and possibly related to the treatment.The serious events cellulitis, purulent discharge and implant site discharge were unexpected and possibly related; however the events are commonly associated with abscess/infections.Potential etiologies for the events include infection associated with the injection procedure; swelling and erythema might also be signs of delayed hypersensitivity.This case meets the criteria for expedited reporting to regulatory authorities due to hospitalization and the surgical intervention.Distribution comment: this case meets the criteria for expedited reporting to regulatory authorities due to hospitalization and the surgical intervention.

Event Description

(b)(6) is a spontaneous report sent on 01-may-2017, with additional information received on 04-may-2017 and 24-may-2017, from a physician which refers to a (b)(6) female patient.The patient's medical history was reported as non-contributory with no filler injections in the past.Allergies included sulfa and penicillin.Concomitant medications included enablex [enablex /01760401/], zoloft [zoloft], and ambien [ambien].On (b)(6) 2017, the patient was injected with 1 ml of restylane silk (lot 13553) to bilateral tear troughs, upper cheeks, and left marionette lines and with 1 ml restylane defyne (lot 14768) to bilateral marionette lines with unknown needle and unknown technique.Eight (8) days later, on (b)(6) 2017, the patient experienced swelling(implant site swelling) and redness(implant site erythema) at the cheeks and marionette lines and pain/tender(implant site pain) at the cheeks.Nine (9) days later, on (b)(6) 2017, the patient contact the physician about the right cheek swelling.Instructed to use ice and do conservative management and seen in the office.Started on clindamycin [clindamycin] for presumptive cellulitis (implant site cellulitis), and 0.1 ml of hyaluronidase [hyaluronidase] injected into right cheek.Ten (10) days later, on (b)(6) 2017, the patient called office with increasing right cheek swelling and some of the left cheek as well.Started on medrol dose pack[methylprednisolone], with differential including delayed hypersensitivity(implant site hypersensitivity) versus cellulitis.Eleven (11) days later, on (b)(6) 2017, patient swelling was decreased but now felt some firmer areas (implant site induration)of the cheeks.Fourteen (14) days later, on (b)(6) 2017, patient seen in office again and now left chin starting to drain (implant site discharge) spontaneously.Firmness of cheeks more discrete and under sterile conditions, 18 gauge needle aspiration was performed of both cheeks, obtaining serosanguinous fluid of the left cheek and purulent/ pus like drainage(purulent discharge) material of the right cheek.Right cheek fluid sent for culture, and patient continued with clindamycin.Culture results preliminarily show wbc only, no organisms.Final culture results no growth.The patient experienced a small firm cystic area at cheeks; both cheeks had abscessed(implant site abscess).Sixteen (16) days later, on (b)(6) 2017, the patient experienced increased pain and swelling in her bilateral cheeks and her left marionette line.On that date the physician attempted to do a decompression using an 11 blade scalpel as corrective treatment, but was only able to do a partial decompression because the patient was very tender/discomfort.On the evening of (b)(6)2017 the md took the patient to the operating room to do a full surgical decompression, incision and drainage (i&d) under anesthesia.Iv (intravenous) vancomycin [vancomycin] 1g given q12h, with one 1 dose given intra-operatively.Purulent material seen of both cheeks and l chin, all three sent for culture.Penrose drains left is all three areas.On (b)(6) 2017, left chin penrose drain had fallen out with nursing dressing change.All cultures still remained negative with only wbc seen, no organisms.Patient having diarrhea so all antibiotics were halted given all negative culture results.On (b)(6) 2017, all four cultures sent came back negative for growth and positive for wbcs only.Clindamycin was discontinued and the patient was discharged from the hospital.Eighteen (18) days later, on (b)(6) 2017, there was significant patient improvement and the patient was discharged to home with dressing changes and no antibiotics.Twenty-one (21) days later, on (b)(6) 2017 the patient followed up with the physician and as of that date the outcome of the patient's swelling, pain, and redness was much improved.The patient only had minor redness around the drain insertion sites and was only mildly tender to palpation.The patient's abscessed areas/cystic areas were resolved.The drains of cheeks kept in as still some minor drainage.Patient was to follow up on (b)(6) 2017 for drain removal.On (b)(6) 2017, both cheeks stopped draining and drains were removed.Left chin started draining again presumably because initial drain was lost early, and incision and drainage performed in the office with drain placement.On (b)(6) 2017, the patient called the physician's office stating the right cheek was a little more swollen and the left side of the chin was closed up, the drain was lost, and the area was sore.The patient denied fever and was restarted on a medrol dose pack.On (b)(6) 2017, the patient emailed the physician stating the swelling was better, but the chin was still sore.On (b)(6) 2017, the patient was started on cipro [ciprofloxacin] 500 bid.On (b)(6) 2017, the patient was seen in the office, both cheeks looked good and were without swelling or fluctuance.The left side of the chin still had 0.5 cm firm area that required puncture to drain a couple of drops of cloudy fluid, but otherwise no frank pus.No cellulitis was seen and the patient was instructed to continue the cipro and stop the medrol dose pack.On 11-may-2017, the patient rescheduled a follow up appointment, because everything looked very good.The reporting physician assessed the case as serious due to the necessity for medical intervention.Treatment for the adverse event: on (b)(6) 2017: 0.1 ml of hyaluronidase in her right cheek and tear trough and was prescribed, clindamycin [clindamycin] as corrective treatment.On (b)(6) 2017: medrol dose pack.On (b)(6) 2017: aspiration of cheeks.Cultures sent.Culture results preliminarily showed wbc only, no organisms.Final culture resulted in no growth.On (b)(6) 2017: partial decompression, full surgical decompression in hospital.Cultures were sent.Penrose drains placed, and 1 dose of intraoperative vancomycin.On (b)(6) 2017: penrose drain in chin fell out with dressing change, antibiotics halted due to diarrhea and negative culture results.On (b)(6) 2017: patient discharged from hospital with no antibiotics.On (b)(6) 2017: i and d of chin and drain inserted.On (b)(6) 2017: medrol dose pack restarted.On (b)(6) 2017: cipro 500 bid started.On (b)(6) 2017: chin required puncture to drain a couple of drops of cloudy fluid, no frank pus.Medrol stopped.On 11-may-2017: follow up visit rescheduled due to positive patient outcome.Outcome at the time of the report: swelling, pain/tender, pus like drainage, redness, firm cystic area, start to drain and delayed hypersensitivity was recovering/resolving.Abscessed, cystic area and cellulitis was recovered/resolved.Tracking list v.1 24-may-2017: concomitant medications, events, treatments, and reporter's seriousness assessment updated.Follow up included all events/ treatments that occurred after (b)(6) 2017.

• Brand Name: RESTYLANE SILK
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE (LMH)
• Manufacturer (Section D): GALDERMA Q-MED; seminariegatan 21; upsala se-752 28; SW
• Manufacturer Contact: christer galderma q-med ; seminariegatan 21; upsala se-752 28, ; SW
• MDR Report Key: 6567993
• MDR Text Key: 75209300
• Report Number: 9710154-2017-00033
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040024/S072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2017
• Device Lot Number: 13553
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/30/2017
• Date Report to Manufacturer: 05/24/2017
• Initial Date Manufacturer Received: 05/01/2017
• Initial Date FDA Received: 05/15/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR