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

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.

• Brand Name: UNK DERMAL FILLER
• Type of Device: IMPLANT, 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 Key: 10649691
• MDR Text Key: 210428842
• Report Number: 3005113652-2020-00579
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P800022
• Number of Events Reported: 1
• 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 Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK DERMAL FILLER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2020
• 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: N
• Patient Sequence Number: 1
• Treatment: ADVIL, AMBIEN
• Patient Age: 60 YR