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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) UNK DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) UNK DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number UNK DERMAL FILLER
Device Problems Device Appears to Trigger Rejection (1524); Patient-Device Incompatibility (2682)
Patient Problem Injury (2348)
Event Date 06/15/2020
Event Type  Injury  
Manufacturer Narrative
Allergan is unable to confirm with the healthcare professional, therefore additional event, product, or patient details are not attainable. The events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Clarification: 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.
 
Event Description
Patient reported being injected with an unspecified dermal filler. The patient was then diagnosed with a tumor in the face and had surgery to remove it. Since the surgery, the patient experienced ¿clear/white balls coming out from the surgery incision. ¿ the patient¿s health care provided advised that it appeared to be filler. The patient was treated with antibiotics. The patient was diagnosed with ¿nose skin cancer. ¿ the patient takes advil and ambien concomitantly. The event is ongoing.
 
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Brand NameUNK DERMAL FILLER
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy 74370
FR 74370
Manufacturer (Section G)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy 74370
FR 74370
Manufacturer Contact
michelle burgess
12331-a riata trace parkway
building 3
austin, TX 78727
7372473605
MDR Report Key10649691
MDR Text Key210428842
Report Number3005113652-2020-00579
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P800022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial
Report Date 10/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK DERMAL FILLER
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2020
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

Patient Treatment Data
Date Received: 10/08/2020 Patient Sequence Number: 1
Treatment
ADVIL, AMBIEN
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