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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

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ALLERGAN LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) Back to Search Results
Catalog Number LAP-BAND ADJUSTABLE GASTRIC BA
Device Problem Device Slipped
Event Date 02/09/2012
Event Type  Injury  
Event Description

Health professional reported explant of a lap-band due to alleged complaint of pt "throwing up for two days,. Dehydrated". The pt was admitted to the hosp, and subsequently developed tachycardia. Pt had emergency surgery, where it was discovered that pt had a slipped band with "three quarter of the stomach in necrotic state". The band was explanted during the surgery, and it was not replaced. There were no diagnostic tests performed before the surgery. Health professional states the serial number for the explanted lap-band device is not known, nor is it available for return, as the hosp discarded the device. It was reported pt has no known allergies, but has history of osteoarthritis, hypothyroidism, polycystic ovarian syndrome, and generalized pain.

 
Manufacturer Narrative

Taper ii. Medwatch sent to fda on: (b)(4) 2012. The access port connector associated with this report has not been returned and was discarded after surgery by the reporter. Based upon the implant date provided the connector type is assumed to be a taper ii. The explanting institution discarded the device when it was explanted and it is no longer available for return. Therefore allergan will not receive it and no analysis or testing will be done. Band slippage, vomiting, dehydration, tachycardia and necrosis are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Device labeling addresses the reported event of band slippage and vomiting as follows: "slippage of the band can occur. Gastro-esophageal reflux, nausea and/or vomiting with early or minor slippage may be in some cases successfully resolved by band deflation. More serious slippages may require band repositioning and/or removal. If there is total stoma outlet obstruction that does not respond to band deflation, or if there is abdominal pain, then immediate re-operation to remove the band is indicated. " device labeling addresses the reported event of necrosis and dehydration as follows: "there were add'l occurrences of these events that were considered to be non-serious. Other adverse events considered related to the lap-band system that occurred in fewer than 1% of subjects included: esophagitis, gastritis, hiatal hernia, pancreatitis, abdominal pain, hernia, incisional infection, infection, redundant skin, dehydration, gi perforation, diarrhea, abnormal stools, constipation, flatulence, dyspepsia, eructation, cardiospasm, hematemesis, asthenia, fever, chest pain, incision pain, contact dermatitis, abnormal healing, edema, paresthesia, dysmenorrhea, hypochromic anemia, band leak, cholecystitis, esophageal dysmotility, esophageal ulcer, esophagitis, port displacement, port site pain, spleen injury, and wound infection. ".

 
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Brand NameLAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
Manufacturer (Section D)
ALLERGAN
goleta CA
Manufacturer (Section G)
UNK ALLERGAN
71 s. los carneros
goleta CA 93111
Manufacturer Contact
karen herrera
71 s. los carneros rd.
goleta , CA 93117
8059615405
MDR Report Key2468810
Report Number2024601-2012-00109
Device Sequence Number1
Product CodeLTI
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 02/09/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/22/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberLAP-BAND ADJUSTABLE GASTRIC BA
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/09/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/22/2012 Patient Sequence Number: 1
Treatment
LEVOTHROID
ADEPEX
METFORMIN
RHINOCORT
CELEBREX
DOXYCYCLINE
ARMOUR THYROID
LASIX
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