MAUDE Adverse Event Report: KATECHO, INC. PADPRO:AD;RTRANS EL/LW, 12X7; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	2001M-C
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	05/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.Device not yet received.
Event or Problem Description
The sales representative reported on behalf of the customer that the 2001m-c, padpro: ad; rtrans el/lw, 12x7, was used in an unknown type of procedure on (b)(6) 2022 and during post-op it was reported ¿staff from campus called reporting that they have experienced a patient injury due to removal of defibrillation pad 2001m-c.Patient's skin was removed.¿ the discovery was made post-op.The pad was placed on the posterior back and no prep of the area was conducted on the patient prior to application.The device was removed with a two-hand splinting technique.A skin tear was visible and apparent after removal of pad.Pre and post skin assessments were done.There was no medical intervention or hospitalization for the patient.Current status of the patient is "discharged." this report is being raised on the basis of injury due to the report of skin tear with removal of the pad.
Event or Problem Description
The sales representative reported on behalf of the customer that the 2001m-c, padpro: ad; rtrans el/lw, 12x7, was used in an unknown type of procedure on (b)(6) 2022 and during post-op it was reported ¿staff from campus called reporting that they have experienced a patient injury due to removal of defibrillation pad 2001m-c.Patient's skin was removed.¿.The discovery was made post-op.The pad was placed on the posterior back and no prep of the area was conducted on the patient prior to application.The device was removed with a two-hand splinting technique.A skin tear was visible and apparent after removal of pad.Pre and post skin assessments were done.There was no medical intervention or hospitalization for the patient.Current status of the patient is "discharged".This report is being raised on the basis of injury due to the report of skin tear with removal of the pad.
Additional Manufacturer Narrative
Received one 2011m-c in original opened package.Lot number was verified.Performed a visual inspection, there was an orange stain throughout the outer pad of the radiotransparent electrode.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.A non-conformance was found; however, it was not related to the manufacture of this product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised to always apply electrodes to flat areas of skin.If possible, avoid folds if skin such as those underneath the breast or those visible on obese individuals.Inadequate pad adhesion can lead to arcing or skin burns.Do not use if conductive polymer gel is dried out.Inspect multifunction electrode for damage, wear and loose connections prior to use.Discard if any damage or wear is found.Do not apply multifunction electrodes over broken skin.Do not apply any substance to the skin surface that will leave a residue (e.G.Lotions, oils, etc.).Do not reapply multifunction electrodes if removed.Apply a new pair.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: PADPRO:AD;RTRANS EL/LW, 12X7
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): KATECHO, INC.; 4020 gannett avenue; des moines IA 50321
• Manufacturer (Section G): KATECHO, INC.; 4020 gannett avenue; des moines IA 50321
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 14684466
• Report Number: 1320894-2022-00126
• Device Sequence Number: 14805260
• Product Code: MKJ
• UDI-Device Identifier: 10653405042587
• UDI-Public: (01)10653405042587(17)250407(10)Y04072204
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K014209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/07/2025
• Device Model Number: 2001M-C
• Device Catalogue Number: 2001M-C
• Device Lot Number: Y04072204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic