MEDLINE 6 INCH SURGICAL RULER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-02-08 for MEDLINE 6 INCH SURGICAL RULER manufactured by Medline Industries.

Event Text Entries

[1712560] During complex hernia repair, we elected to use a single piece of mesh, given that the intact fascia between the 2 defects was very small and attenuated in appearance. Careful intra-abdominal measurements were made with a measuring tape to determine that the left sided hernia was 3x4cm and the right sided hernia was 5x5cm with a left sided/midline attenuation of an add'l 3x3cm. Together we determined that a 20x22cm piece of polyester mesh would provide 5cm overlap in all directions. We then used the enseal to strip the urachal remnant and midline fat in the lower abdominal wall along with the associated peritoneum to expose the fascia. We exposed the under surface of the symphysis pubis to the dome of the bladder. We then cut a piece of parietex to size -20x22- and introduced it into the abdomen after the port to the left of the umbilicus was up-sized to a 12mm port. We initially secured the mesh to the anterior abdominal wall using two 2-0 gore-tex sutures. These sutures were passed through the abdominal wall with a gore-tex suture passer. Once the mesh was positioned such that there were 5cm margins on each side of the defect, an absorbatack laparoscopic suture packer was used to place the mesh onto the anterior abdominal wall. Of note, when we went to remove the measuring tape, it had become softened and ripped, leaving a portion sandwiched between the mesh and the anterior abdominal wall just above the pubis. After considering the risks of opening to retrieve this paper tape, it was considered safer to leave it in place. It was decided to leave the tape where it was and disclosed this to the pt and family. Dates of use: (b)(6) 2011.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5019369
MDR Report Key1987886
Date Received2011-02-08
Date of Report2011-02-08
Date of Event2011-01-21
Date Added to Maude2011-02-16
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameMEDLINE 6 INCH SURGICAL RULER
Generic NameMEDLINE 6 INCH SURGICAL RULER, MADE OF 10 MIL POLYLITH SYNTHETIC
Product CodeFTY
Date Received2011-02-08
Lot Number10JD2406
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2011-02-08

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