MEDLINE

Additional Manufacturer Narrative

IT WAS REPORTED THAT FOLLOWING A "LEFT LUMBAR 4-LUMBAR 5 MICRODISCECTOMY" ON (B)(6) 2026 WHERE THE NEUROSPONGES WERE USED, THE "PATIENT CONTINUES TO HAVE HEALING ISSUES." THE CUSTOMER REPORTED "PERSISTENT DRAINAGE, FLUID COLLECTION SUBCUTANEOUSLY AND WOUND OPENS BACK UP" AS WELL AS "ERYTHEMA ALONG INCISION SITE." THE CUSTOMER STATED, "CULTURES HAVE BEEN DONE AND NO INFECTION PRESENT." PER THE CUSTOMER, "THE PATIENT HAD TO RETURN TO SURGERY AT (B)(6) HOSPITAL ON (B)(6) 2026 FOR AN IRRIGATION AND DEBRIDEMENT OF THE WOUND" AND THAT THE "WOUND STILL HAS NOT HEALED AND NOW PATIENT WAITING TO HAVE A WOUND VAC PLACED TO ASSIST IN THE HEALING PROCESS." IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. BASED ON THE INFORMATION REVIEWED, THIS IS A REPORTABLE EVENT AS DEFINED UNDER 21 CFR 803.3. THE CUSTOMER WAS UNABLE TO CONFIRM THE LOT NUMBER INVOLVED, BUT DID PROVIDE A LIST OF LOTS THAT MAY HAVE BEEN INVOLVED IN THE REPORTED INCIDENT. POTENTIALLY INVOLVED LOTS ARE LISTED BELOW WITH THEIR APPLICABLE EXPIRATION AND MANUFACTURING DATES. LOT 6052103035- EXPIRATION DATE: 03/2026, MANUFACTURING DATE: 03/2021 LOT 6052205042- EXPIRATION DATE: 05/2027, MANUFACTURING DATE: 05/2022 LOT 6051906049- EXPIRATION DATE: 06/2024, MANUFACTURING DATE: 06/2019 LOT 6052001061- EXPIRATION DATE: 01/2025, MANUFACTURING DATE: 01/2020 LOT 6051801064- EXPIRATION DATE: 01/2023, MANUFACTURING DATE: 01/2018.

Description of Event or Problem

IT WAS REPORTED THAT FOLLOWING A "LEFT LUMBAR 4-LUMBAR 5 MICRODISCECTOMY" ON (B)(6) 2026 WHERE THE NEUROSPONGES WERE USED, THE "PATIENT CONTINUES TO HAVE HEALING ISSUES." THE CUSTOMER REPORTED "PERSISTENT DRAINAGE, FLUID COLLECTION SUBCUTANEOUSLY AND WOUND OPENS BACK UP" AS WELL AS "ERYTHEMA ALONG INCISION SITE."