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

Catalog Number UNK HA DERMAL FILLER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The events of "serious allergic reaction" and "almost lost the skin" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device labeling addresses the reported event(s) as follows: "undesirable effects.The patients must be informed that there are potential side effects associated with implantations of this product, which may occur immediately or may be delayed.These include, but are not limited to: ¿ inflammatory reactions (redness, oedema, erythema, etc.) which may be associated with itching or pain on pressure or both, occurring after injection.These reactions may last for a week.".

Event Description

Company representative reported on behalf of a patient who reported via social media that they were injected with an unknown hyaluronic acid dermal filler in the nose approximately over a year ago and developed a "serious allergic reaction" an unspecified amount of time later.Patient also noted they ¿almost lost the skin." no further information was provided.

• Brand Name: UNK HA 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: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 7048724
• MDR Text Key: 92626155
• Report Number: 9617229-2017-04787
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HA DERMAL FILLER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2017
• 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