15FR FULL FLUTED 4 CHANNEL STERILE

MDR report key: 6420260 · Received March 21, 2017

Report

Report Number: 1836161-2017-00024
Event Type: Injury
Date Received: March 21, 2017
Date of Event: February 2, 2017
Report Date: February 22, 2017
Manufacturer: ASPEN SURGICAL PRODUCTS, CALEDONIA
Product Code: GCY
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UT, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

ON (B)(6) 2017 WE PERFORMED AN ABDOMINOPLASTY WITH LIPOSUCTION OF BACK/FLANKS AND LATERAL CHEST ON A (B)(6) FEMALE PATIENT. THE SURGERY WAS PERFORMED WITHOUT INCIDENT AND 2 JP DRAINS WERE PLACES IN THE ABDOMEN. THE DRAINS WERE REPORTED TO BE WELL INTACT AND DRAINING NORMALLY. ON (B)(6) 2017 THE PATIENT WAS SEEN BY THE SURGEON, DR. (B)(6) FOR HER 10-DAY POST-OPERATIVE APPOINTMENT AND REMOVAL OF HER DRAINS. AT THIS POINT THE RIGHT DRAIN WAS REMOVED WITHOUT INCIDENT. IT WAS REPORTED TO THE PHYSICIAN THAT THE LEFT DRAIN HAD NO LONGER BEEN DRAINING. THE LEFT DRAIN REMOVAL WAS ATTEMPTED AND THE DISTAL END OF THE DRAIN WAS REMOVED WITHOUT RESISTANCE AND GENTLE PRESSURE WHEN THE PROXIMAL END DETACHED FROM THE REST OF THE DRAIN. THE PHYSICIAN ATTEMPTED TO REMOVE THE PROXIMAL END OF THE DRAIN IN THE OFFICE WITHOUT SUCCESS. ON (B)(6) 2017 THE PATIENT ENDURED ANOTHER PROCEDURE, EXPLORATION OF ABDOMEN AND REMOVAL OF DRAIN AT (B)(6) SURGERY CENTER. THE DRAIN WAS EASILY FOUND AND RETRIEVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
204429	15FR FULL FLUTED 4 CHANNEL STERILE	WOUND DRAIN	GCY	ASPEN SURGICAL PRODUCTS, CALEDONIA	332188	91136

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR		Required Intervention