ProGen PRP Advantage PROGEN-A30Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850034511573), received between Sep 24, 2022 and Nov 1, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Off-Label Use” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 1, 2022Off-Label Use; Off-Label Use

  ENLARGED LYMPH NODES AND PRP INJECTION SITE ITCHING AND SWELLING WHERE PRP OBTAINED FROM THE DEVICE WAS USED TO SUPPORT HAIR GROWTH.

  Patient problems: Swelling/ Edema

  MAUDE report 15709451 ↗
• InjurySep 27, 2022Off-Label Use; Off-Label Use

  NODULE DEVELOPMENT UNDER THE SKIN WHERE PRP OBTAINED FROM THE USE OF THE DEVICE WAS USED TO SUPPORT HAIR GROWTH.

  Patient problems: Subcutaneous Nodule

  MAUDE report 15495526 ↗
• InjurySep 24, 2022Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method

  PRESUMED ASPIRATION AND SUBSEQUENT INJECTION OF SEPARATION GEL UNDER THE SKIN WHICH IS PRESUMED TO HAVE CAUSED AN ALLERGIC REACTION. ALL EVIDENCE SUPPORTS USER ERROR.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Nodule

  MAUDE report 15479447 ↗