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

Model Number CLR222US

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 11/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested and received.What is the procedure name? total knee arthroplastie.What is the procedure date? no confirmed date.Skin reaction on (b)(6) 2021.Skin reactions occurred post-op, and were identified "around (b)(6) 2021".Confirmed that one of the tka patients presented with a skin reaction on (b)(6) 2021 per the pictures that the pa provided me with.What does the reaction look like and how large of an area does the reaction cover? occurred on incision underneath the prineo mesh.Redness, irritation, and similar presentation.Do you have any pictures of the reaction? yes.Please explain of what consisted the traditional care to treat the reaction.Mds and pas that reactions resolved once the prineo was removed and the patient was treated with antibiotics and anti-inflammatory medication.Was there any other medical or surgical intervention performed to treat the reaction (product removed; re-operation; re-closure; prescription medication)? if so, please specify.Product removed and medicine prescribed per the answer above ^.No further information provided by surgeon and pa.If medication was required, please clarify if it was prescription strength.Patient was treated with antibiotics and anti-inflammatory medication.What is the most current patient status? fine now and healed" per surgeon and pa.Can you identify the product code and lot number of the product that was used? clr222us.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? yes.According to the surgeon and pa previously been exposed to prineo as a skin closure method on previous surgeries less than a year prior, with no reaction during their prior use of prineo.Additional information has been requested, however not received to date.If further details are received at a later date a supplemental medwatch will be sent.What was the procedure date? what date /day post op was the reaction noted? 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? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? were any patch or sensitivity tests performed? patient demographics: initials / id, gender, age or date of birth; bmi.Patient pre-existing medical conditions (ie.Allergies, history of reactions) no product will be returned.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported a patient underwent a total knee arthroscopy surgery on an unknown date in 2021 and a topical skin adhesive was used.Post op on (b)(6) 2021 patient experienced skin reactions/dermatitis under the adhesive.Once removed reaction resolved with traditional care and the treated with antibiotics and anti-inflammatory medication.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.Additional information was requested, and the following was obtained: what was the procedure date? i was not provided with exact procedure dates by the surgeon and his pa.I was only informed that these reactions occurred in late 2021, and that one of these patients presented with the attached images during a follow-up visit on (b)(6) 2021.What date /day post op was the reaction noted? the patient in the attached images presented during a follow-up office visit on (b)(6) 2021.Please describe how was the adhesive was applied.Applied per the ifu instructions for all 3 procedures per the pa.What prep was used prior to, during or after adhesive use? not known at this time.Was a dressing placed over the incision? if so, what type of cover dressing used? not known at this time.Is the patient hypersensitive to pressure sensitive adhesives? not known at this time.Were any patch or sensitivity tests performed? not known at this time.Patient demographics: initials / id, gender, age or date of birth; bmi not known at this time.Patient pre-existing medical conditions (ie.Allergies, history of reactions) not known at this time.

• 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
• MDR Report Key: 13589138
• MDR Text Key: 287025756
• Report Number: 2210968-2022-01278
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CLR222US
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2022
• 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