DR FOG TREATED SPONGE, STERILE
Received Mar 31, 2026
Report 3002750084-2026-00029 · MDR key 24746675
Device
Product problems
- Unsealed Device Packaging
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL ASSESSMENT DETERMINED THAT HTE SAMPLE HAD POOR SEAL INTEGRITY. THE MOST PROBABLY ROOT CAUSE FOR POOR SEAL INTEGRITY IS A MANUFACTURING ERROR, WHERE THE TRIM SCRAP ENTERED THE SEAL CAUSING THE SEAL INTERFERENCE DURING THE POUCH MANUFACTURING PROCESS. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Additional Manufacturer Narrative
THE DEVICE IS IN PROCESS OF BEING RETURNED FOR EVALUATION, AND THE INVESTIGATION IS ONGOING. ONCE WE HAVE ADDITIONAL RELEVANT INFORMATION IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
COMPLAINANT ALLEGES "STERILIZED FAILURE".