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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE FER LIGATOR, HEMORRHOIDAL

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COOK IRELAND LTD SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE FER LIGATOR, HEMORRHOIDAL Back to Search Results
Catalog Number HMBL-4-TRI
Device Problem Unclear Information (4052)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/22/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
As reported to customer relations: "i would like to register a complaint for short shot at (b)(6) hospital (b)(4). Please let me know if you need additional information. " additional information provided by (b)(6) on 30apr2019: "the physician attempted to band the hemorrhoids, but the device seemed to deflate the hemorrhoids. I filled out everything that i know about the procedure. ".
 
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Brand NameSHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE
Type of DeviceFER LIGATOR, HEMORRHOIDAL
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
Manufacturer (Section G)
COOK IRELAND LTD
o halloran road
national technology park
limerick
Manufacturer Contact
heather ryan
o halloran road
national technology park
limerick 
061334440
MDR Report Key8615532
MDR Text Key145234715
Report Number3001845648-2019-00212
Device Sequence Number1
Product Code FER
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060623
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberHMBL-4-TRI
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/23/2019
Event Location Hospital
Date Manufacturer Received04/26/2019
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

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