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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 Problem Obstruction/Occlusion (2422)
Event Type  Injury  
Manufacturer Narrative
The filler was injected into the patient and is not accessible for return. The syringe was not returned for evaluation. Further information regarding event, product, or patient details has been requested. No additional information is available at this time. The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event. This is a known potential adverse event addressed in the product labeling.
 
Event Description
Healthcare professional (hcp) reported patient was injected in ck 1, ck 4 and ck 3 area, on the zygomatic bone, lateral cheek area and chin area with [unspecified] dermal filler. Patient had a swollen blood vessel above the zygomatic area. Patient was treated with hyalase the affected area due to a suspected pressure on the vessel. The event is ongoing.
 
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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 Key14854483
MDR Text Key294942061
Report Number3005113652-2022-00393
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
P800022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2022
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 Received06/16/2022
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 Initial

Patient Treatment Data
Date Received: 06/29/2022 Patient Sequence Number: 1
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