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

Lot Number 16704

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

Patient Problems Dysphagia/ Odynophagia (1815); Dyspnea (1816); Headache (1880); Irritation (1941); Nausea (1970); Swelling (2091); Vomiting (2144); Urticaria (2278); No Code Available (3191)

Event Date 11/19/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturer narrative: the reported lot number was valid.Pharmacovigilance comment: the serious expected event of dyspnoea was considered possibly related to the treatment.Serious criteria include the need for medical interventions.Potential contributory factor includes injection of the product to the posterior tracheal wall of laryngeal stoma (off label use).Alternative etiology includes patient's medical history.The non-serious expected events of urticaria, irritation and swelling at implant site and non-serious unexpected event dysphagia and dysphonia were considered possibly related to the treatment.Alternative cause for event of dysphagia and dyspnoea may be due to swelling, possible panic attack.The non-serious unexpected events of headache, nausea, vomiting, panic attack and urticaria (on chest, stomach and thigh/graft scar) were considered unrelated to the treatment.Alternative etiology includes history of laryngectomy.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 26-nov-2019 by a consumer which refers to a (b)(6)-year-old male patient with skin type fitzpatrick iii-iv.This case narrative also contain additional information received from an other health professional (nurse) on 27-nov-2019.The patient's medical history included laryngeal cancer, chemotherapy, radiation therapy, total laryngectomy in 2015, tracheoesophageal prosthesis that allows patient to speak periodically and usually improved with the help of filler, allergic to scopolamine/keppra.In past, the patient had previously received treatment with juvederm ultra xc to the posterior tracheal wall of laryngeal stoma on (b)(6) 2019 without issue but it did not last long.Concomitant treatments included albuterol [albuterol], alprazolam [alprazolam], calcitriol [calcitriol], calcium carbonate [calcium carbonate], famotidine [famotidine], fentanyl [fentanyl], fluoxetine [fluoxetine], ipratropium [ipratropium], levothyroxine [levothyroxine], magnesium oxide [magnesium oxide], oxycodone [oxycodone], pentoxifylline [pentoxifylline], vitamin e [vitamin e] and methylprednisone [methylprednisolone].On 19-nov-2019, the patient received treatment with total 1 ml of restylane (lot 16704) to the posterior tracheal wall of laryngeal stoma (off label use) with needle provided in the package and unknown technique.On 19-nov-2019, immediately after treatment with restylane, the patient experienced headache (headache).On the same day, while driving to home developed difficulty breathing/shortness of breath (dyspnoea), difficulty swallowing/dysphagia (dysphagia), irritation (implant site irritation), felt overly swollen (implant site swelling), nausea (nausea) and vomiting (vomiting).The patient visited emergency department, where diagnosed as possible panic attack (panic attack).The patient was discharged on the same day and difficulty breathing resolved, however continued to have difficulty swallowing, irritation and hard to speak/trouble voicing (dysphonia).On (b)(6) 2019, the patient wife spoke with healthcare professional who advised patient take methylprednisone [methylprednisolone] 4 milligram once daily for 3 days, that did not help and was still having difficulty swallowing, irritation and finding it hard to speak.On (b)(6) 2019, 06 days later, the patient experienced hives (implant site urticaria) at neck and hives on chest, stomach and thigh/graft scar (urticaria).On (b)(6) 2019, the patient was prescribed 2 tablets of benadryl[diphenhydramine hydrochloride], 50 milligram oral daily.Hives were improved in all areas except for thigh graft scar.The reporting nurse informed that the patient still having some dysphagia and trouble voicing.Outcome at the time of the report: felt overly swollen was unknown.Difficulty breathing/shortness of breath was recovered/resolved.Difficulty swallowing/dysphagia was not recovered/not resolved.Irritation was not recovered/not resolved.Hard to speak/trouble voicing was not recovered/not resolved.Hives was recovering/resolving.Possible panic attack was recovered/resolved.Headache was recovered/resolved.Nausea was recovered/resolved.Vomiting was recovered/resolved.Hives on chest, stomach and thigh (graft scar) was not recovered/not resolved.Restylane injected in throat/voicebox was recovered/resolved.

• Brand Name: RESTYLANE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED; seminariegatan 21; uppsala, SE-75 2 28; SW SE-752 28
• Manufacturer (Section G): GALDERMA Q-MED; seminariegatan 21; uppsala, SE-75 2 28; SW SE-752 28
• Manufacturer Contact: amy poteate ; 14501 north freeway; fort worth, TX 76177 ; 8175615353
• MDR Report Key: 9495390
• MDR Text Key: 188987459
• Report Number: 9710154-2019-00110
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 16704
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR