Stimulan® Rapid Cure 620-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 50601557110270), received between Aug 18, 2015 and Mar 26, 2018 — classified as 1 death.

The most frequently reported specific device problem is “Compatibility Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K141830); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathMar 26, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  REPORT BEING SUBMITTED TO MATCH CUSTOMERS REPORT. 20 FEB 2018 IT WAS REPORTED BY THE HOSPITAL PHARMACIST THAT A PATIENT PRESENTED WITH RENAL FAILURE 48 HOURS, POST SURGERY. SURGERY - PJI, EXPLANTATION SEPTIC LEFT KNEE. THE FOLLOWING ANTIMICROBIALS WERE GIVEN POST AND PRE SURGERY: PRE-OP: 2GM CEFAZOLIN IVPB, 1500MG VANCOMYCIN IVPB BACITRACIN IRRIGATION, 2.4GM TOBRAMYCIN & 8MG VANCOMYCIN MIXED IN 80GM PMMA 2GM VANCOMYCIN MIXED WITH 5CC, STIMULAN RAPID CURE TO MAKE BEADS; 1GM VANCOMYCIN IN WOUND BED; POST-OP: 2GM NAFCILLIN IVPB. ON 29 FEB 2018 INFORMATION RECEIVED REGARDING THE DEATH OF THE PATIENT, 15 DAYS POST EVENT.

  Patient problems: Renal Failure

  MAUDE report 7369050 ↗
• Aug 18, 2015Compatibility Problem

  (B)(6) 2015: PATIENT UNDERWENT AN EXCISION BIOPSY OF TWO LARGE TUMORS IN THE LEFT ANTERIOR AXILLA, WITH PRIMARY CLOSURE, AND A JP DRAIN. A 5CC OF STIMULAN RAPID CURE MIXED WITH VANCOMYCIN AND GENTAMICIN WAS IMPLANTED DUE TO PATIENT'S PRIOR WOUND HEALING ISSUES AND PREVIOUS INFECTIONS. THE PATIENT RECEIVED THREE IV DOSES OF CLINDAMYCIN AND ONE EXTRA STRENGTH TYLENOL POST-OP. CLEAN MARGINS WERE OBTAINED ON THE BIOPSIES. THE PATIENT DID NOT HAVE ANY MEDICATION CHANGES PRE/POST-OP, NOR DID SHE RECEIVE ANY MEDICATIONS IN THIS PERIOD THAT SHE HAD NOT TAKEN PREVIOUSLY. (B)(6) 2015: PATIENT WAS ASYMPTOMATIC AND HAS NOT REQUIRED ANY ADDITIONAL PAIN MEDICATION. (B)(6) 2015: PATIENT DEVELOPED ITCHING AROUND THE SURGICAL SITE. (B)(6) 2015: THE PATIENT'S SYMPTOMS PROGRESSED TO A SYSTEMIC ALLERGIC REACTION. THE PATIENT VISITED HER PRIMARY CARE PHYSICIAN AND BEGAN TAKING H1/H2 BLOCKERS (BENADRYL AND ZANTAC). THE PATIENT INCREASED HER BENADRYL AND SYMPTOMS WORSENED. WHEN THE PATIENT REPORTED TONGUE SWELLING, THE SURGEON RECOMMENDED SHE COME BACK IN TO BE SEEN. (B)(6) 2015: THE PATIENT WAS DIAGNOSED IN THE ER WITH SERUM SICKNESS/LOW GRADE REACTION TO AN UNKNOWN CAUSE. THERE IS NO ANAPHYLACTIC REACT

  Patient problems: Skin Irritation; Wheal(s)

  MAUDE report 5009703 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141830. One submission often covers many models, so check the product and lot details in each record.

• Z-0638-2021 · Nov 12, 2020 · Terminated
  Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure.