DIV81 PRIMARY CARE
Received May 28, 2025 · Event occurred Aug 1, 2024
Report 1417592-2025-00260 · MDR key 22100677
Device
Generic name
Div81 Primary Care
Manufacturer
Medline Industries, LpCatalog number
DIV81
Lot number
84324030051
Product problems
- Material Integrity Problem
- Material Integrity Problem
Patient
45 YR · Female
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
ACCORDING TO THE FACILITY IN (B)(6) 2024, DURING AN "OBSTETRIC PROCEDURE (C-SECTION)", A PIECE OF THE LAP SPONGE "TORE" AND REQUIRED REMOVAL FROM THE PATIENT'S ABDOMEN.
Additional Manufacturer Narrative
ACCORDING TO THE FACILITY IN (B)(6) 2024, DURING AN "OBSTETRIC PROCEDURE (C-SECTION)", A PIECE OF THE LAP SPONGE "TORE" AND REQUIRED REMOVAL FROM THE PATIENT'S ABDOMEN. PER THE FACILITY THE PROCEDURE WAS ABLE TO BE COMPLETED AND AT THIS TIME THERE HAS BEEN NO REPORT OF INJURY RELATED TO THE REPORTED INCIDENT. THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.