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

Catalog Number CLR222

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

Patient Problems Inflammation (1932); Skin Irritation (2076)

Event Date 10/22/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested and the following was obtained: please describe how was the adhesive was applied.Put on top of the closed wound as per ifu.What prep was used prior to, during or after prineo use? prep used prior to case.Was a dressing placed over the incision? if so, what type of cover dressing used? yes.Dressing was placed on top for a few days.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no.Is the patient hypersensitive to pressure sensitive adhesives? no.Were any patch or sensitivity tests performed prior to use? no.What is the physicians opinion of the contributing factors to the reaction? not provided what is the most current patient status? not provided.Patient demographics: initials / id; age or date of birth; bmi; initials (b)(6); dob: (b)(6); male.Was prineo / demabond or skin adhesive used on the patient in a previous surgery or wound closure? unknown.

Event Description

It was reported that a (b)(6) yr old male patient underwent a spinal procedure for decompression l3/4, l4/5 and l5/s1 on (b)(6) 2019 and topical skin adhesive was used.It was reported that the patient had a small reaction to the topical skin adhesive.On (b)(6) 2019, the practice manager removed the dressing and the inflammation / reaction was noticed.The patient presented to gp and was given a topical steroid cream.On (b)(6) 2019 the patient has improved and was advised to wash well in shower.Additional information has been requested.

• Brand Name: DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3,; san lorenzo
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9384414
• MDR Text Key: 168619296
• Report Number: 2210968-2019-90359
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031237339
• UDI-Public: 10705031237339
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: CLR222
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2019
• 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
• Patient Age: 67 YR