inforMED
InjuryFHO

ORIGIN

Received May 26, 1999 · Event occurred May 18, 1999

Report 228960 · MDR key 228960

Device

Generic name

Preperitoneal Distention Balloon

Model number

*

Catalog number

PDB1000

Lot number

0102991

Product problems

  • Balloon rupture
  • Replace
  • Physical Resistance
  • Device Or Device Fragments Location Unknown

Patient

37 YR

  • Internal Organ Perforation
  • Surgery, prolonged
  • Therapy/non-surgical treatment, additional
  • Hematuria
  • Surgical procedure, additional
  • Hospitalization required

Narrative

Description of Event or Problem

WHILE HAVING A LAPAROSCOPIC REPAIR OF RT INGUINAL HERNIA, A STRUCTURAL BALLOON WAS INSERTED. BALLOON INFLATED WITH 4 HAND SQUEEZES OF HAND INSUFFLATOR. BALLOON POPPED, SURGEON INSERTED TELESCOPE AND CONFIRMED DEFLATED BALLOON. REMOVED STRUCTURAL BALLOON & INSERTED A PRE-PERITONEAL BALLOON, AND THEN TELESCOPE & FOUND URINARY BLADDER HAD BEEN COMPROMISED. BLADDER REPAIR DONE, TEMPORARY SUPRAPUBIC TUBE IN PLACE FOR 7-14 DAYS.