MAUDE Adverse Event Report: A&E MEDICAL CORPORATION A&E MEDICAL CORPORATION - SUCTION COAGULATOR

Model Number 050-005

Device Problems Device Issue (2379); Device Operational Issue (2914)

Patient Problem Burn(s) (1757)

Event Date 05/23/2017

Event Type  Injury  

Manufacturer Narrative

The complained upon suction coagulator device (050-005, lot 198c) was returned to a&e medical for investigation.The device was received on 7/24/2017.(ref.(b)(4)) the device was reviewed through the clear plastic packaging upon receipt and found to be satisfactory visually without opening the package.The device has been sent to the sterilizer as part of the a&e medical decontamination process on 8/3/2017.The device has not returned as of this preliminary report.The device will be reviewed and electrically tested upon its return, estimated to be the week of 8/14/2017.A follow up report shall be submitted upon completion of the investigation.

Event Description

Patient was found to have lower lip swelling, thought to be due to electrical burn from suction coagulator.Patient was treated with polysporin and observed closely.

Manufacturer Narrative

The complained upon suction coagulator device (050-005, lot 198c) was returned to a&e medical for investigation.The device was received on 7/24/2017.(ref.Rga 170717-02) the device was reviewed through the clear plastic packaging upon receipt and found to be satisfactory visually without opening the package.The device has been sent to the sterilizer as part of the a&e medical decontamination process on 8/3/2017.The device has not returned as of this preliminary report.The device will be reviewed and electrically tested upon its return, estimated to be the week of 8/14/2017.A follow up report shall be submitted upon completion of the investigation.Upon review of returned device after decontamination process it was observed the returned device was in a sealed pouch that was never opened.A call to the complainant confirmed the returned device was not the device complained upon.The complained upon device was discarded by the user.The returned device was from the same lot number and thus a&e medical investigated and tested the returned device.(b)(4).

Event Description

Patient was found to have lower lip swelling, thought to be due to electrical burn from suction coagulator.Patient was treated with polysporin and observed closely.

• Brand Name: A&E MEDICAL CORPORATION - SUCTION COAGULATOR
• Type of Device: SUCTION COAGULATOR
• Manufacturer (Section D): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer (Section G): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer Contact: bill kilby ; 5206 asbury road; farmingdale, NJ 07727 ; 7329382266
• MDR Report Key: 6786367
• MDR Text Key: 82457316
• Report Number: 2242056-2017-00004
• Device Sequence Number: 1
• Product Code: FEH
• UDI-Device Identifier: 10841291104865
• UDI-Public: 10841291104865
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K881413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/01/2021
• Device Model Number: 050-005
• Device Catalogue Number: 050-005
• Device Lot Number: 198C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention