MAUDE Adverse Event Report: ETHICON INC. DERMABOND HV 0.5ML VIAL - 6EA; ADHESIVE, TOPICAL SKIN

Catalog Number AHV6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Wound Dehiscence (1154)

Event Date 01/01/2023

Event Type  Injury  

Event Description

It was reported a patient underwent an unknown procedure on an unknown date in 2023 and topical skin adhesive was used.Unspecified issue.Patient had wound dehiscence consequence, additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information provided: was surgery delayed due to the reported event? --> unknown, was procedure successfully completed? --> unknown, were fragments generated? --> unknown, if yes, were they removed easily without additional intervention? --> unknown, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown, is the patient part of a clinical study --> unknown, additional information has been requested and received.Did this issue contribute to any patient adverse event?¿yes, wound dehiscence.¿ device return status?.- already couriered.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.It was noted in the event description: "when opened found dried and no adhesive inside" if that is the case, what was used on the patient instead of the dermabond to close the skin? how was wound dehiscence reported as a patient event related to the dermabond if the product was unable to be used.Please explain and describe.What is the alleged deficiency of the product? is photo available of patient dehiscence? what was the procedure date? what date /day post op was the dehiscence noted? was any prescription strength medication prescribed? please specify? was any surgical intervention performed? please describe how was the adhesive was applied.What prep was used prior to, during or after adhesive use? was a dressing placed over the incision? if so, what type of cover dressing used? patient demographics: initials / id, gender, age or date of birth; bmi patient pre-existing medical conditions (ie.Allergies, history of reactions) product code and/or lot of product used? current patient status.What is the physician¿s opinion as to the etiology of or contributing factors to this event? is product available to return for analysis? name of surgeon? no product is available for return.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: DERMABOND HV 0.5ML VIAL - 6EA
• Type of Device: ADHESIVE, TOPICAL SKIN
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17607445
• MDR Text Key: 321802762
• Report Number: 2210968-2023-06037
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K100423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AHV6
• Device Lot Number: TCBHTE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other