MAUDE Adverse Event Report: TEOXANE RHA4; RESILIENT HYALURONIC ACID

Lot Number 211111C0

Device Problem Off-Label Use (1494)

Patient Problems Erythema (1840); Injection Site Reaction (4562)

Event Date 04/21/2022

Event Type  Injury  

Event Description

Above my lips has been splitting; my face had little blister all over the affected area [injection site vesicles].Bruising at the nasolabial fold injection site on the left side only [injection site bruising].The skin is so raw and dry which is why it is painful to touch [injection site pain].Blanching of the nasolabial fold injection site on the left side only [injection site discolouration].The skin is so raw and dry [injection site dryness].Rha4 to upper cheeks [off label use].United states report received from a healthcare professional on 25-apr-2022.A physician reported that a female patient of 42 years of age received rha product for unknown indication, on (b)(6) 2022.A 2ml volume of rha4 injection was applied to nasolabial folds and cheeks using retro tracing and fanning injection technique.No needle was used from the box and it was unknown if a cannula was used for the administration of the rha4 product.No previous cosmetic procedures were done.Medical history was not provided.Concomitant medications, and food supplements were not provided.On (b)(6) 2022, after one day the prescriber reported blanching in the area of nasolabial folds, nasal area and upper lips.Nitroglycerin paste was applied to the affected area as treatment.The outcome of the events bruising at the nasolabial fold injection site on the left side only and blanching of the nasolabial fold injection site on the left side only were resolved.The remaining events were resolving/recovering.It is unknown if the product was available for return.The intensity was moderate.No additional information was available at the time of this report.Follow up was received from a health care professional on (b)(6) 2022: patient initial, age, sex, race, weight and pregnancy were added.The rha4 product was added injection site and intensity was added.Batch number, outcome, previous cosmetic procedures were added, and narrative was updated.Follow up was received from a health care professional on 16-may-2022, upgraded the case from a non-expedited to an expedited case.This is this an initial submission for this case: a volume of rha4 1 cc in total: 0.6 cc on the left side.0.4 cc on the right side; and 1 cc was applied to the nasolabial folds and cheeks using intradermal injection technique and needles supplied from the box.A cannula was used for the administration of the product.On (b)(6) 2022, following the injection of rha4, the patient had blanching of the nasolabial fold injection site on the left side only, additionally the patient experienced bruising at nasolabial fold injection site, which was mild, pinpoint size.As a treatment for blanching on the same day the prescriber applied nitro bid paste for five minutes.The prescriber wiped off the paste and reapplied for another ten minutes.On the same day ((b)(6) 2022), as further treatment, the patient injected with 100 units of vitrase in normal saline to dissolve the filler and applied a warm compress.An unspecified period (2022) following the administration of rha4, the patient's skin is so raw and dry which is why it is painful to touch.Additionally, the patient reported little blisters all over the affected area.The patient stated that her lips were healing, and that vaseline was helping with the splitting.The outcome of the event bruising resolved a week after which was on an unknown date in (b)(6) 2022.The outcome of the event blanching was resolved on (b)(6) 2022.The outcome of the event the skin is so raw and dry was resolving.No additional information was available at the time of the report.Case comment: a causal relationship between the rha4 and reported events is assessed as possible based on the compatible temporal relationship and the lack of alternative etiologies that can be identified based on the reported information.The company will continue monitoring the benefit-risk profile for the product.

Event Description

My face had little blister all over the affected area [injection site vesicles] bruising at the nasolabial fold injection site on the left side only [injection site bruising] above my lips has been splitting [chapped lips] the skin is so raw and dry which is why it is painful to touch [injection site pain] blanching of the nasolabial fold injection site on the left side only [injection site discolouration] the skin is so raw and dry [injection site dryness] mild erythema [erythema] rha4 to upper cheeks [off label use].United states report received from a healthcare professional on 25-apr-2022.A physician reported that a female patient of 42 years of age received rha product for unknown indication, on (b)(6) 2022.A 2ml volume of rha4 injection was applied to nasolabial folds and cheeks using retro tracing and fanning injection technique.No needle was used from the box and it was unknown if a cannula was used for the administration of the rha4 product.No previous cosmetic procedures were done.Medical history was not provided.Concomitant medications, and food supplements were not provided.On 22-apr-2022, after one day the prescriber reported blanching in the area of nasolabial folds, nasal area and upper lips.Nitroglycerin paste was applied to the affected area as treatment.The outcome of the events bruising at the nasolabial fold injection site on the left side only and blanching of the nasolabial fold injection site on the left side only were resolved.The remaining events were resolving/recovering.It is unknown if the product was available for return.The intensity was moderate.Health effect - clinical code: 4562, injection site reaction.Health effect - device code: 1494, user used incorrect product for intended use.No additional information was available at the time of this report.Follow up was received from a health care professional on 11-may-2022: patient initial, age, sex, race, weight and pregnancy were added.The rha4 product was added injection site and intensity was added.Batch number, outcome, previous cosmetic procedures were added, and narrative was updated.Follow up was received from a health care professional on 16-may-2022.The follow up information received resulted in upgrade of the case to reportable mdr due to medical importance.This is this an initial submission for this case: a volume of rha4 of 0.6 ml on the left side.0.4 ml on the right side; and 1.0ml was applied to the cheeks, nasolabial folds and upper lips using intradermal injection technique and needles supplied from the box.A cannula was used for the administration of the product.On (b)(6) 2022, following the injection of rha4, the patient had blanching of the nasolabial fold injection site on the left side only, additionally the patient experienced bruising at nasolabial fold injection site, which was mild, pinpoint size.As a treatment for blanching on the same day the prescriber applied nitro bid paste for five minutes.The prescriber wiped off the paste and reapplied for another ten minutes.On the same day (b)(6) 2022, as further treatment, the patient injected with 100 units of vitrase in normal saline to dissolve the filler and applied a warm compress.An unspecified period (2022) following the administration of rha4, the patient's skin is so raw and dry which was why it was painful to touch.Additionally, the patient reported little blisters all over the affected area.The patient stated that her lips were healing, and that vaseline was helping with the splitting.The reporter confirmed that there were no signs of necrosis.It was reported that the symptoms were noticed immediately after injection and continued for the next 5-7 days before fully resolving.The skin was back to normal with some mild erythema.The outcome for mild erythema was unknown.The outcome of the all other events was recovered/resolved.Health effect - clinical code: 4562(above my lips has been splitting; my face had little blister all over the affected area) injection site reaction.Health effect - clinical code: 4562(bruising at the nasolabial fold injection site on the left side only), injection site reaction.Health effect clinical code: 4562(which is why it is painful to touch), injection site reaction.Health effect-clinical code: 4562(blanching in the area) injection site reaction.Health effect - clinical code: 4562(the skin is so raw and dry) injection site reaction.Health effect - device code: 1494(rha4 to upper cheeks) off-label use.Health effect - clinical code: 1840(mild erythema) erythema.Follow up was received from a health care professional on 15-jun-2022.Gtin number added, volume of injection added, outcome updated as recovered, new event erythema was added, above my lips has been splitting; my face had little blister all over the affected area" has been split in to two events, "my face had little blister all over the affected area" and "above my lips has been splitting and narrative updated accordingly.Case comment: a causal relationship between the rha4 and reported events is assessed as possible based on the compatible temporal relationship and the lack of alternative etiologies that can be identified based on the reported information.The company will continue monitoring the benefit-risk profile for the product.

• Brand Name: RHA4
• Type of Device: RESILIENT HYALURONIC ACID
• Manufacturer (Section D): TEOXANE; les charmilles; rue de lyon, 105; geneva, CH-12 03; SZ CH-1203
• MDR Report Key: 14655984
• MDR Text Key: 294853299
• Report Number: 3007772056-2022-00009
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2022,06/15/2022

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: Health Professional
• Device Expiration Date: 03/15/2024
• Device Lot Number: 211111C0
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/13/2022
• Distributor Facility Aware Date: 04/25/2022
• Device Age: 0 YR
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/10/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: White