MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. UNK_SMOKE EVACUATION; ZIP PEN SMOKE EVAC PENCIL, E-Z CLEAN

Catalog Number UNK_SMOKE EVACUATION

Device Problems Flaked (1246); Difficult or Delayed Activation (2577)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 09/08/2022

Event Type  Injury  

Event Description

See medwatch # mw51112090.

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.No lot or batch number was provided therefore a device history could not be done.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: what is the correct product code that was used for the procedure? what was the lot number of the device? are there any photos of the burn that you could share with us in regards to the burn? if yes, please send to productcomplaint1@its.Jnj.Com.Are there any photos of the device that you could share with us in regards to the burn? if yes, please send to productcomplaint1@its.Jnj.Com.When were the burns first noticed? what medical intervention was used to treat the burn? (such as salve or stitches) besides the burn, did the patient experience any adverse consequence due to the issue? are there any anticipated long-term effects from the burn or injury? what is the current status of the patient? what was the surgical procedure? does the surgeon believe there is there an alleged deficiency to the device that led to patient burn and if so why? what generator was being used? what power levels was generator set to? was becton, dickinson and company notified of their product issue chloraprep hi-lite orange? will the device be returned for analysis? if yes, to whom should the shipper kit be sent to? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: UNK_SMOKE EVACUATION
• Type of Device: ZIP PEN SMOKE EVAC PENCIL, E-Z CLEAN
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek road; cincinnati OH 45242
• Manufacturer (Section G): MEGADYNE MEDICAL PRODUCTS, INC.
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 15579233
• MDR Text Key: 301561828
• Report Number: 1721194-2022-00089
• Device Sequence Number: 1
• Product Code: FYD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMOKE EVACUATION
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention