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

Model Number CLR222US

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Nerve Damage (1979); Pain (1994); Rash (2033); Skin Discoloration (2074); Skin Inflammation/ Irritation (4545)

Event Date 07/01/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription medication)? if so, please specify.Yes.I consulted with my dermatologist who prescribed me with high dose prednisone to treat the severe type 4 delayed type hypersentitivity reaction to dermabond which led to more infections with treatment with diflucan and shortly after i stopped prednisone as a result of the severe reaction of the skin acting more or less like a cast over my leg or possible retraction during surgery, i have suffered from peroneal nerve injury with numbness and nerve pain over the top of my left foot and area over my first and second toes.If medication was required, please clarify if it was prescription strength.Prednisone 60 mg x 3 days, 40 mg x 3 days, 20 mg x 3 days.Triamcinolone acetonide ointment 0.1%.Tacrolimus ointment 0.1%.Bethamethasone dipropionate cream 0.05%.Neosporin otc.Extensive wound care for 3 weeks (it was a good thing that i am a general surgeon).What is the most current patient status? permanent discoloration on left leg where dermabond was applied.This involved the entire anterior surface of my left lower leg from knee to ankle and the lateral surface where excessive dermabond had dripped all the way down the or table and exposing the posterior aspect of the left leg to dermabond i am still dealing with residual rash lesions in secondary locations throughout my bilateral legs.At one point, i had rashes on my neck and back as well.My dermatologist told me that it is common to see secondary site of rash when the exposure was severe and excessive.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.

Event Description

It was reported a patient underwent left leg surgery on (b)(6) 2022 and topical skin adhesive was used.On an unknown date in (b)(6) 2022, post op, the patient had a severe reaction to the product.It was noted that the physician assistant used adhesive over the incision.In addition, did not wipe away any additional fluid that came from the vial that ran down the leg.Patient was treated with: prednisone 60 mg x 3 days, 40 mg x 3 days, 20 mg x 3 days.Triamcinolone acetonide ointment 0.1%, tacrolimus ointment 0.1%, bethamethasone dipropionate cream 0.05%, neosporin otc and extensive wound care for 3 weeks.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Name of leg surgery? 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? was patient screening done prior the procedure, e.G.Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? patient demographics: initials / id, age or date of birth; bmi has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? product lot of product used? name of surgeon? 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).Additional information has been requested and received.Name of surgery - all i was told was removal of hardware from previous surgery.Reaction was noted immediate - same day of surgery, (b)(6) 2022 the adhesive was applied after surgery.The ps was unaware that this patient had known reaction to adhesives.The patient is a general surgeon and she was very specific before proceedure that she had these allergies.Some how the pa did not see the notes on the board in the room at time of surgery and applied prineo any way.The pa extruded too much of the prineo fluid and it ran down the leg.The pa did not wipe up excess fluid.Patient screening was done and she was clear regarding her sensitivity.Patient do not know age.(approximately early 50s with normal bmi) the patient had previous exposure to adhesives and was clear to surgeon in screening that she allergies.Those allergies were written on the board in the surgical suite during surgery.No product lot available.Surgeon (b)(6).The surgeon was not in the room when the pa used this product and was very frustrated that this occurred.Dr.Facilitated a training and in servicing of all as and staff after this occurred to help insure it did not repeat.The patient, who i have noted is a general surgen, told me that she believes that prineo is a very good product, but that it should not be used on her or others who have similar issues.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Please provide clarification: confirm the procedure date.And the date of the patient's reaction.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 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: 15564430
• MDR Text Key: 301481045
• Report Number: 2210968-2022-08260
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• 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: 10/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female