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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COSMAN MEDICAL DISPOSABLE GROUNDING PAD
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COSMAN MEDICAL DISPOSABLE GROUNDING PAD Back to Search Results
Model Number DGP-PMC-25
Device Problem No Apparent Adverse Event (3189)
Patient Problems Bacterial Infection (1735); Burn(s) (1757)
Event Type  Injury  
Manufacturer Narrative
The grounding pads will not be returned as they were discarded by the facility.
 
Event Description
A report was received that the patient was burned on the upper outer thigh lower buttock region.The burn was not located near the grounding electrode.It was assessed that the event was related to the surgical technique and that due care was not taken to protect against indirect current path across the thighs.It was also assessed that the most likely cause is the skin becoming moist, allowing a high resistance path to form from one leg to the other.It is unknown at this time whether the patient received medical intervention for the burn.
 
Manufacturer Narrative
Additional information was received that the patient had an infection and that the wound site was being monitored.The patient was administered antibiotics for the infection.It is unknown how the burn was treated other than due care was given to the patient and no further adverse event was reported.
 
Event Description
A report was received that the patient was burned on the upper outer thigh lower buttock region.The burn was not located near the grounding electrode.It was assessed that the event was related to the surgical technique and that due care was not taken to protect against indirect current path across the thighs.It was also assessed that the most likely cause is the skin becoming moist, allowing a high resistance path to form from one leg to the other.It is unknown at this time whether the patient received medical intervention for the burn.
 
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Brand Name
DISPOSABLE GROUNDING PAD
Type of Device
GROUNDING PAD
Manufacturer (Section D)
COSMAN MEDICAL
22 terry ave
burlington MA 01803
Manufacturer (Section G)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key6902226
MDR Text Key87713867
Report Number3006630150-2017-03838
Device Sequence Number1
Product Code GXI
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K050084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 05/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Model NumberDGP-PMC-25
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/04/2017
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 Sequence Number1
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