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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED CORPORATION CLEARTRACE 2 CONDUCTIVE ADHESIVE GEL ADULT ECG ELECTRODES CLEARTRACE 2 ADULT ECG ELECTRODES

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CONMED CORPORATION CLEARTRACE 2 CONDUCTIVE ADHESIVE GEL ADULT ECG ELECTRODES CLEARTRACE 2 ADULT ECG ELECTRODES Back to Search Results
Catalog Number 2700-005
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Rash (2033); Reaction (2414)
Event Date 03/13/2012
Event Type  No Answer Provided  
Event Description
It was reported, "patient developed rash after use of pads. They were on 24-hour telemetry monitoring from approximately 9:00 am march 12th to 9:00 am march 13th. The rash was described as 'red streaks'. " rash was treated with benadryl.
 
Manufacturer Narrative
The actual device utilized in this reported incident has not been returned to conmed, only lot samples have been returned. Photographs have not been sent of the skin reaction. The quality engineering evaluation has not yet commenced. When this evaluation is completed, a supplemental report will be submitted.
 
Manufacturer Narrative
The cleartrace 2 ecg electrode is intended for use during electrocardiographic (ecg) procedures. This product is a single use, disposable device. The cleartrace 2 ecg electrodes utilized in this incident were discarded by the end-user. The original devices or pictures of the devices or skin reaction were not available. Only lot samples in unopened packages were returned to conmed corporation; therefore, an investigation on the suspect device cannot be accomplished. The returned devices were examined in the quality engineering laboratory. No visual gel or adhesive discrepancies were observed on the sample electrodes. Dhr/lhr, device history record/lot history record, review has verified that the devices were produced according to current and approved procedures and material specifications. Non-conformances regarding the product's identity, quality, safety, effectiveness, or performance were not identified during manufacture. There could be multiple of possible causes either manufacturing or user related issues for this failure mode. These electrodes are tested and passed for biocompatibility. All ecg electrodes materials are tested for cytotoxicity, sensitization, and intracutaneous factor per iso approved testing. In process inspection & visual checks were done to ensure proper production of the devices. It is unknown if there was any skin preparation prior to the utilization of this product. Lack of or improper skin preparation could result in solvents under the electrode site such as skin lotions or skin soap which could have caused the skin irritation. The ifu, instructions for use, warns that, "the electrode site should be dry before electrode application. Fluids, including skin cleansing solutions, lotions, or soapy water may cause skin irritation and loss of adhesion. Keep electrode site dry". The ifu further instructs, "the electrode sites should be clean, dry, and free from skin oil prior to electrode application". It is also unknown how the ecg electrode was removed from the patient. A rapid removal of the ecg electrode could cause irritation/damage to the patient's skin surface. The ifu warns, "rapid removal of the electrode from the patient may cause skin damage. If the electrode is difficult to remove, use alcohol to moisten the adhesive-skin interface". The most likely cause of this failure mode is a patient allergic reaction to a component of the device such as electrode adhesive and /or gel. The complaint cannot be confirmed or unconfirmed at this time due to the lack of actual device samples utilized in the incident. The complaint investigation has not identified or confirmed any manufacturing defects associated with the returned devices; therefore, no corrective action is recommended at this time. Future complaints will be tracked through conmed complaint methodology. Conmed is considering this complaint closed.
 
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Brand NameCLEARTRACE 2 CONDUCTIVE ADHESIVE GEL ADULT ECG ELECTRODES
Type of DeviceCLEARTRACE 2 ADULT ECG ELECTRODES
Manufacturer (Section D)
CONMED CORPORATION
525 french road
utica NY 13502 599
Manufacturer (Section G)
CONMED CORPORATION
525 french road
utica NY 13502 599
Manufacturer Contact
stephen casanova
525 french road
utica, NY 13502-5994
3156243463
MDR Report Key2496476
MDR Text Key2631981
Report Number1320894-2012-00019
Device Sequence Number1
Product Code DRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091856
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/15/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2012
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number2700-005
Device Lot Number1112051
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/14/2012
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/05/2011
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: 03/20/2012 Patient Sequence Number: 1
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