MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE; CUTANEOUS TISSUE ADHESIVE WITH MESH

Catalog Number CLR422

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Skin Inflammation/ Irritation (4545)

Event Date 12/06/2021

Event Type  Injury  

Event Description

It was reported a patient underwent an unknown procedure on (b)(6) 2021 and topical skin adhesive was used.Patient had an aggressive allergic reaction to adhesive.Patient was re-admitted and put on oral corticosteroids to manage the severe allergic reaction.Patch testing was conducted on an area away from the wound site which produced an aggressive ,florid and relatively quick reaction to the dressing even within 24 hours.Wounds not infected highly irritated rash associated with the dressing.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: in the last 4 to 6 weeks several patients have had an aggressive allergic reaction to the prineo 42 dressing.Wounds not infected highly irritated rash associated with the dressing.A number of patients were re-admitted an put on oral corticosteroids to manage the severe allergic reaction.Patch testing was conducted on an area away from the wound site which produced an aggressive ,florid and relatively quick reaction to the dressing even within 24 hours.This reaction has occurred in a number of patients recently.The incidence is not high we estimate around (b)(4) in the last month.We have not commonly observed this reaction in the past.Did the patient experience a post-op device malfunction? unknown, did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? yes, did the patient require revision surgery or hardware removal? no, if no, was there any additional medical intervention required such as x-rays, additional procedures, prescriptions?oral corticosteroids for severe allergic reaction , patient status/ outcome / consequences yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? allergic reaction, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: yes, if yes, describe admission to hospital with oral corticosteroids, is the patient part of a clinical study unknown.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.How many patients were reported with reaction? please advise of the following information about each patient event: procedure name? procedure date? what was the date of the reaction, day post op? is a photo of the reaction available (label reference number for patient as needed) 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) has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? current patient status.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.No product is available for return.The single complaint was reported with multiple events.There are no additional details regarding the additional events.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).Additional information has been requested and obtained.If further details are received at a later date a supplemental medwatch will be sent.Id: (b)(6), female, 37yrs, no known allergies.Procedure: open itb release on (b)(6) 2021, reaction- (b)(6) 2021 (7days post op).Dressing: ac - to company directions.Surgical prep: chlorhexidine 2% (red).Photo provided, dressing-yes-mepilex border, nk allergies, no sensitivity to adhesive, no patch tests, yes had previous exposure, yes used prineo/db, recovered.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.Product complaint # (b)(4).

• Brand Name: DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE
• Type of Device: CUTANEOUS TISSUE ADHESIVE WITH MESH
• 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: 13238237
• MDR Text Key: 288885751
• Report Number: 2210968-2022-00349
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K163645
• 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: 01/31/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: CLR422
• Device Lot Number: RHBCKT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 01/12/2022
• Supplement Dates Manufacturer Received: 12/13/2021
• Supplement Dates FDA Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female