FDA Adverse Event Injury Summary report: N

3007321028-2019-00004

MDR report key: 8541730 · Received April 23, 2019

Report

Report Number: 3007321028-2019-00004
Event Type: Injury
Date Received: April 23, 2019
Report Date: April 17, 2019
PMA / PMN Number: K092096
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: 003

Narratives

Description of Event or Problem · 1

AROA BIOSURGERY BECAME AWARE OF A PATIENT-REPORTED EVENT #MW5084906 VIA THE COMPANY'S US AGENT. AROA INITIATED A VOLUNTARY RECALL (Z-0377-2019, Z-0378-2019 AND Z-0379-2019) IN NOVEMBER 2018 AS A PREVENTIVE MEASURE RESULTING FROM ISSUES OBSERVED DURING INTERNAL IN-PROCESS DYE PENETRATION TESTING OF EDT POUCHES. TO-DATE THERE HAVE BEEN NO REPORTS OR CONFIRMATION OF SEAL INTEGRITY ISSUES WITH ANY DEVICES IN THE NINE (9) RECALLED LOTS, THUS NO IMPACT TO THE STERILITY OF THOSE DEVICES. ENDOFORM END-USERS (PATIENTS) RECEIVE FREQUENT (E.G. DAILY TO WEEKLY) DRESSING CHANGES, WOUND ASSESSMENT AND NECESSARY MEDICAL INTERVENTION. THE HEALTH HAZARD EVALUATION CONDUCTED BY A LEADING WOUND CARE CLINICAL EXPERT CONCLUDED THAT GIVEN THE HIGH RATES OF BACTERIAL COLONIZATION TYPICALLY ASSOCIATED WITH CHRONIC WOUNDS, AND EXISTING MEDICAL PRACTICES TO REDUCE OR CONTROL INFECTION IT IS UNLIKELY THAT APPLICATION OF A NON-STERILE DEVICE WOULD RESULT IN ANY ADDITIONAL MEDICAL INTERVENTION NOT ALREADY BEING UNDERTAKEN FOR THE PATIENT.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other