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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN MANUFACTURER UNK DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE

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UNKNOWN MANUFACTURER UNK DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number UNK DERMAL FILLER
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Abscess (1690); Obstruction/Occlusion (2422)
Event Type  Injury  
Event Description
Healthcare professional reported via social media injecting a patient with an unspecified dermal filler. The patient experienced a ¿vascular occlusion. ¿ the patient was treated with 300 u of hylenex mixed with lidocaine into the top lip and along the nasolabial folds and with 325 mg aspirin. After an hour, ¿steady progress¿ was noted. The patient was sent home with 325 mg aspirin 2x/day, nitroglycerine paste, viagra, keflex, topical mupirocin with lidocaine, and advised warm compress. The next morning, the patient experienced ¿pustular lesions (pimple-like looking bumps). ¿ the patient was advised to go to the er to evaluate possible hyperbaric oxygen chamber treatment to prevent necrosis. A plastic surgeon deemed it was not necessary. The event status is unknown.
 
Manufacturer Narrative
Allergan is unable to confirm with the healthcare professional, therefore additional event, product, or patient details are not attainable. The event of "vascular occlusion" and "pustular lesions (pimple-like looking bumps)" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event. The filler was injected into the patient and is not accessible for return. The syringe was not returned for evaluation. This is a known potential adverse event addressed in the product labeling.
 
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Brand NameUNK DERMAL FILLER
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
UNKNOWN MANUFACTURER
Manufacturer (Section G)
UNKNOWN MANUFACTURER
Manufacturer Contact
chris sprague
12331-a riata trace parkway
building 3
austin, TX 78727
8479375615
MDR Report Key13178784
MDR Text Key283975553
Report Number3005113652-2022-00003
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P800022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician Assistant
Type of Report Initial
Report Date 01/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK DERMAL FILLER
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 01/06/2022 Patient Sequence Number: 1
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