MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE; SURGICAL SEALANT

Model Number CLR222

Device Problems Delivered as Unsterile Product (1421); Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2022

Event Type  malfunction  

Event Description

It was reported a patient underwent an unknown procedure on (b)(6) 2022 and topical skin adhesive was used.Packaging was labeled "¿sample for demonstration, prohibited sale, use in humans prohibited¿.A non-clinical sample for hands-on demonstration was received with open packaging.There were no reported adverse patient consequences.

Manufacturer Narrative

Product complaint # (b)(4).Additional information received: 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 however not received.Attempts have been made to obtain the device, however not received to date.If further details are received at a later date a supplemental medwatch will be sent.What is the lot number? was the label with the information ¿sample for demonstration, prohibited sale, use in humans prohibited¿ on both devices (used and not used)? were there any patient consequences? if so, was there any associated medical or surgical intervention? is the device available to be returned for evaluation? if yes, what is the device return status? note: events reported on mw# 2210968-2022-05109.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.

Manufacturer Narrative

Product complaint # (b)(4).H3 evaluation: this is an analysis of three photos submitted for review.Upon visual inspection of the images, a box and a sample of product code with j&j logo label could be observed.In addition, the pen dispenser and box has a label overlay that reads "not for human use." this label is used to identify material for sampling.However, no conclusion could be reached on the open seal issue as the sample was not returned for analysis.The manufacturing records could not be reviewed as the batch number is unknown.Based on the information currently available, the label issue was identified during the investigation of the photo received.This product issue will be addressed through ethicon quality system.According to the photo, the complaint is observed.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 PRINEO 22CM MSH 3.8ML ADHESIVE
• Type of Device: SURGICAL SEALANT
• 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: 14918765
• MDR Text Key: 303236673
• Report Number: 2210968-2022-05108
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031237339
• UDI-Public: 10705031237339
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLR222
• Device Catalogue Number: CLR222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1