MAUDE Adverse Event Report: GALDERMA Q-MED AB RESTYLANE-L; IMPLANT, DERMAL, FOR AESTHETIC USE

Lot Number 17327

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

Patient Problems Abscess (1690); Purulent Discharge (1812); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091); No Code Available (3191)

Event Date 05/19/2020

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comment: the serious expected events of swelling at implant site and purulent discharge were considered possibly related to the treatment.Serious criteria include the need for multiple medical and surgical interventions.The non-serious expected events of pain, erythema and hypersensitivity at implant site were considered possibly related to the treatment.Potential contributory factor for swelling include injection procedure and purulent discharge could be due to improper aseptic precautions leading to infection.The restylane-l was used off label.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: the reported lot number was valid.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 01-jun-2020 by an other health professional which refers to a (b)(6) year-old female patient.The patient medical history included allergy to bactrim.No information about medical history has been provided.The patient does not routinely take any other products or medications.The patient had previously received treatment with restylane-l or juvederm, 6-7 years ago and had similar reactions.Hence a test spot was performed in the patient forearm on (b)(6) 2020.On (b)(6) 2020, the patient received treatment with 0.7 ml restylane-l (lot 17327) to the lower lid and cheek area bilaterally using an unknown needle type and injection technique.The restylane-l injected to eyelid (off label use).7 days later, on (b)(6) 2020, patient contacted hcp and reported she had experienced swelling (implant site swelling), tenderness/burning sensation (implant site pain) at injection sites.Hcp put patient on keflex [cefalexin] and advised patient to ice the areas.They thought it was an allergic reaction(implant site hypersensitivity).On (b)(6) 2020, the patient visited hcp office, and presented with extreme swelling and tenderness, worse on the right side of face.Right eye was almost completely swollen shut.Hcp drained the right area of the face that was swollen and pus came out(purulent discharge).The patient was placed on doxycycline [doxycycline], a 10 day course and rifampin [rifampicin].A bacterial culture was sent out and was negative.On (b)(6) 2020, the patient came back into the hcp office.The right side of the face was getting better and becoming less swollen but hcp redrained the area again and more pus came out.On (b)(6) 2020, pt came back into hcp office and the left side of the face was more swollen.Hcp drained left side of face.It was at this appointment that the hcp noticed that a test spot, which had been injected with restylane-l on (b)(6) 2020, in the forearm, was red (implant site erythema) and swollen.Hcp punctured these test spot and pus came out.The patient was still on doxycycline and rifampin.Areas of injection site were still swollen, tender and red bilaterally, as well as the test spot being swollen and red.Outcome at the time of the report: swelling was not recovered/not resolved.Pus came out was recovered/resolved.Tenderness/burning sensation was not recovered/not resolved.Red was not recovered/not resolved.Allergic reaction was unknown.Restylane-l injected to eyelid was recovered/resolved.

Manufacturer Narrative

Pharmacovigilance comment: the serious expected events of abscess and swelling at implant site were considered possibly related to the treatment.Serious criteria include the need for multiple medical and surgical interventions.The non-serious expected events of pain, erythema, hypersensitivity at implant site and purulent discharge were considered possibly related to the treatment.Potential contributory factors for swelling include injection procedure and abscess could be due to improper aseptic precautions leading to infection.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: the reported lot number was valid.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 01-jun-2020 by an other health professional which refers to a 62-year-old healthy black female patient.The patient had fitzpatrick skin type v-vi.The patient medical history included allergy to bactrim, sulfa.No information about medical history has been provided.The patient does not routinely take any other products or medications.The patient had previously received treatment with restylane-l or juvederm, 6-7 years ago and had similar reactions.Hence a test spot was performed in the patient forearm on (b)(6) 2020 and read as negative on (b)(6) 2020, so was treated with restylane-l.On (b)(6) 2020, the patient received treatment with 0.7 ml restylane-l (lot 17327) to the bilateral cheek area using an unknown needle type and injection technique.7 days later, on (b)(6) 2020, patient contacted hcp and reported she had experienced swelling(implant site swelling), tenderness/burning sensation(implant site pain) at injection sites.Hcp put patient on keflex [cefalexin] and advised patient to ice the areas.They thought it was an allergic reaction(implant site hypersensitivity).On (b)(6) 2020, the patient visited hcp office, and presented with bilateral abscess(implant site abscess), extreme swelling and tenderness, worse on the right side of face.Right eye was almost completely swollen shut.Hcp incised and drained the abscess and pus came out/purulent discharge(purulent discharge).The patient was placed on doxycycline [doxycycline], a 10 day course and rifampin [rifampicin].A bacterial culture was sent out and was negative.On (b)(6) 2020, the patient came back into the hcp office.The right side of the face was getting better and becoming less swollen but hcp redrained the area again and more pus came out.On (b)(6) 2020, pt came back into hcp office and the left side of the face was more swollen.Hcp drained left side of face.It was at this appointment that the hcp noticed that a test spot, which had been injected with restylane-l on (b)(6) 2020, in the forearm, was red(implant site erythema) and swollen.Hcp punctured these test spot and pus came out.The patient was still on doxycycline and rifampin.Areas of injection site were still swollen, tender and red bilaterally, as well as the test spot being swollen and red.Abscess was again drained on (b)(6) 2020 and (b)(6) 2020.On (b)(6) 2020, forearm patch test eventually turned positive and developed abscess.Outcome at the time of the report: swelling was recovering/resolving.Abscess was recovering/resolving.Pus came out/purulent discharge was recovering/resolving.Tenderness/burning sensation was recovering/resolving.Red was recovering/resolving.Allergic reaction was unknown.Tracking list: v.0 initial.V.1 fu received on 13-aug-2020 from the physician: serious event abscess at implant site added.Event verbatim of purulent discharge updated.Off label use of device event deleted.Second reporter, suspect device implant location, event location, severity, outcome and reporter causality were updated.

• Brand Name: RESTYLANE-L
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• MDR Report Key: 10184716
• MDR Text Key: 201185308
• Report Number: 9710154-2020-00052
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P040024/S039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/31/2022
• Device Lot Number: 17327
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR