REALIZE ADJ GASTRIC BAND-C

Report

• Report Number: 3005992282-2010-00391
• Event Type: Malfunction
• Date Received: December 3, 2010
• Date of Event: December 1, 2009
• Report Date: November 10, 2010
• Manufacturer: OBTECH MEDICAL SARL_
• Product Code: LTI
• Removal / Correction Number: NA
• Product Problem: Yes
• Report Source: Manufacturer report
• Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED.

Description of Event or Problem · 1

IT WAS REPORTED BY THE PATIENT THAT SHE CONTACTED HER SURGEON'S OFFICE WHEN SHE BEGAN TO EXPERIENCE PAIN IN HER GROIN POST IMPLANT A REALIZE GASTRIC BAND. HER SURGEON AND THE OTHER SURGEON IN THE PRACTICE WERE NOT AVAILABLE, SO THE SURGEON'S OFFICE REFERRED THE PATIENT TO HER PRIMARY PHYSICIAN. THE PRIMARY PHYSICIAN ORDERED AN XRAY AND SENT THE PATIENT BACK TO A SURGEON WITH THE RESULTS. THE PATIENT HAD A SECOND SURGERY AT THE END OF 2009 BECAUSE THE TUBING HAD COME LOOSE FROM THE PORT AND WAS DRAPED DOWN INTO THE PATIENT'S GROIN. THERE WERE NO OTHER REPORTED COMPLICATIONS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	REALIZE ADJ GASTRIC BAND-C	IMPLANT, INTRAGASTRIC FOR MORBID OBESITY	LTI	OBTECH MEDICAL SARL_	UNK	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 1

• Pain

Product problems · 1

• Disconnection

Source type · 1

• Consumer

Type of report · 1

• Initial submission