inforMED
MalfunctionOOD

GALAFLEX 3D

Received Mar 18, 2025 · Event occurred Feb 26, 2025

Report 1213643-2025-00189 · MDR key 21631857

Device

Generic name

Absorbable Mesh

Model number

100042-06

Catalog number

SH3D06

Lot number

LXHW0007

Product problems

  • Device Contamination with Chemical or Other Material
  • Device Contamination with Chemical or Other Material

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

AS REPORTED, GALAFLEX 3D HAD A BUG WITHIN THE PACKAGE. BASED ON PHOTO REVIEW, ON THE CORNER OF THE TYVEK ENVELOPE THERE IS A SMUDGE/DISCOLORATION OR FOREIGN MATERIAL PRESENT. PHOTOS PROVIDED CANNOT ASSIST IN DETERMINING THAT WHAT IS SEEN IN THE IMAGES IS A SMUDGE/DISCOLORATION OR FOREIGN MATTER, HOWEVER, CAN CONCLUDE THAT WHAT IS PRESENT IS NOT A BUG. BASED ON THE INFORMATION PROVIDED AND WITHOUT HAVING THE SAMPLE TO EVALUATE, NO CONCLUSIONS CAN BE MADE. REVIEW OF MANUFACTURING RECORDS SHOWS PRODUCT WAS MADE TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF (B)(4) UNITS. NOTE: SECTION A THROUGH F: THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

AS REPORTED, THE GALAFLEX 3D HAD A "BUG" WITHIN THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

AS REPORTED, GALAFLEX 3D HAD A BUG WITHIN THE PACKAGE. BASED ON PHOTO REVIEW, ON THE CORNER OF THE TYVEK ENVELOPE THERE IS A SMUDGE/DISCOLORATION OR FOREIGN MATERIAL PRESENT. PHOTOS PROVIDED CANNOT ASSIST IN DETERMINING THAT WHAT IS SEEN IN THE IMAGES IS A SMUDGE/DISCOLORATION OR FOREIGN MATTER, HOWEVER, CAN CONCLUDE THAT WHAT IS PRESENT IS NOT A BUG. BASED ON THE INFORMATION PROVIDED AND WITHOUT HAVING THE SAMPLE TO EVALUATE, NO CONCLUSIONS CAN BE MADE. REVIEW OF MANUFACTURING RECORDS SHOWS PRODUCT WAS MADE TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF (B)(4) UNITS. ADDENDUM: H11: THIS IS AN ADDENDUM TO THE INITIAL MDR SUBMITTED. THIS SUPPLEMENTAL MDR IS SUBMITTED TO CORRECT THE IMDRF ANNEX C CODE. UPDATED FIELDS. CORRECTED FIELD: H6 (IMDRF ANNEX C GRID) NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

AS REPORTED, THE GALAFLEX 3D HAD A "BUG" WITHIN THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.