ECOLAB CLEANOP KIT SURGICAL POSITIONING STRAP CHSMF-02D

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-22 for ECOLAB CLEANOP KIT SURGICAL POSITIONING STRAP CHSMF-02D manufactured by Ecolab.

Event Text Entries

[68407298] Patient was undergoing a laparoscopic appendectomy. He was positioned in tredelenburg with a 45 degree tilt to the left side. A strap was placed around his thighs for positioning. During the procedure, the plastic loop on the strap broke and the patient slid toward the floor. He was caught and eased down by the surgeon and techs who were on the left side of the bed. At the time the strap broke the patient had 3 trocars inserted in his abdomen as well as an endotracheal tube that was dislodged. His head did not hit the floor, but did hit the iv pole stand behind the table. He was lifted back onto the table, the trocars were removed, he was re-prepped and draped and trocars inserted into the original tracts. There was no damage noted upon direct visualization. He was re-intubated easily without evidence of trauma. He sustained a small hematoma on his left forehead that disappeared within 2-3 days. X-rays demonstrated no injuries. He remained hospitalized for 8 days of iv antibiotics due to a diagnosis of peritonitis prior to surgery.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5068092
MDR Report Key6356235
Date Received2017-02-22
Date of Report2017-02-22
Date of Event2017-02-14
Date Added to Maude2017-02-24
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameECOLAB CLEANOP KIT SURGICAL POSITIONING STRAP
Generic NameBEDDING DISPOSABLE, MEDICAL
Product CodeKME
Date Received2017-02-22
Model NumberCHSMF-02D
Lot NumberJ17025
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerECOLAB
Manufacturer Address1 ECOLAB PLACE ST. PAUL MN 55102 US 55102


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-02-22

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