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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED LARGO DIGIT TRAP FINGER GRASPING DEVICE, 20 EA APPARATUS, TRACTION, NON-POWERED

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CONMED LARGO DIGIT TRAP FINGER GRASPING DEVICE, 20 EA APPARATUS, TRACTION, NON-POWERED Back to Search Results
Catalog Number 9906
Device Problem Insufficient Information (3190)
Patient Problem Laceration(s) (1946)
Event Date 06/22/2021
Event Type  malfunction  
Manufacturer Narrative
The device will not be returned for evaluation and no photographic evidence has been provided; therefore, the reported event cannot be verified. A device history record review cannot not be conducted as no lot number was provided. A lot history review cannot be conducted as no lot number was provided. A two-year review of complaint history revealed there has been a total of one complaint, regarding one device, for this device family and failure mode. During this same time frame (b)(4) devices have been manufactured and shipped worldwide. Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4). This issue will continue to be monitored through the complaint system to assure patient safety. Note: this report is being resubmitted following an unsuccessful submission attempt on 12aug21 due to a system error.
 
Event Description
This complaint was created due to the receipt of a medwatch report (mw5102137) on 19jul21. The current complaint database has been researched for this event and there were no findings. The report was found to be written against the (b)(4), stating ¿product caused laceration to digit. ¿. The medwatch did not indicate serious injury, only malfunction; therefore, there was no report of injury, medical intervention, or hospitalization for the patient. Further assessment questions were sent to the reporter and 3-attempts were made to gain further information. However, to date, the reporter has not responded to our request. This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
 
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Brand NameDIGIT TRAP FINGER GRASPING DEVICE, 20 EA
Type of DeviceAPPARATUS, TRACTION, NON-POWERED
Manufacturer (Section D)
CONMED LARGO
11311 concept blvd
largo FL 33773
Manufacturer (Section G)
CONMED LARGO
11311 concept blvd
largo FL 33773
Manufacturer Contact
john berga
11311 concept blvd
largo, FL 33773
7273995358
MDR Report Key12385840
MDR Text Key270372976
Report Number1017294-2021-00322
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9906
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2021
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?
Type of Device Usage

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