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

Model Number CLR222

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

Patient Problem Local Reaction (2035)

Event Date 10/15/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # pc (b)(4).Date sent to the fda: 12/1/2020 the following information was requested and was obtained.To date the device has not been received.If the further details are received at a later date a supplemental medwatch will be sent.Were there any other medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids)? if so, please clarify.¿ what is the most current patient status if known/feedback from patient¿s wound monitoring? the patient presented to ed over the weekend as she was concerned with the amount of exudate from the wound.She has been prescribed steroid cream & saline wash to the area & is currently tolerating this.¿ was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? no history of prineo/derambond being used in the past.The following information was requested however not obtained.¿ can you identify the lot number of the product that was used? please describe how was the adhesive was applied.What prep was used prior to, during or after prineo 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? does the patient use or exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? 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.

Event Description

It was reported a patient underwent a c3/4 anterior cervical discectomy an fusion & c4/5 anterior discectomy & disc replacement (for left arm pain & cord compression) on (b)(6) 2020 and topical skin adhesive with mesh was used.The patient developed a reaction within 2 days of the dressing being applied while an inpatient.Patient was discharged with home nursing to monitor the wound, antibiotics not required.Patient prescribed steroid cream & saline wash to the area & is tolerating.Additional informaiton has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to fda: 2/10/2021.Additional information was requested and was received.If further details are received at a later date a supplemental medwatch will be sent.Please describe how was the adhesive was applied- as per protocol.Mesh wash applied over the incision.Very small amount of glue was applied to the middle of the mesh along the incision & left to dry what prep was used prior to, during or after prineo use?2% chlorhexidine surgical prep was a dressing placed over the incision? if so, what type of cover dressing used? yes- opsite dressing post-op 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? no.Does the patient use or exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)?- yes lashes- no reactions to glue.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.

• 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
• MDR Report Key: 10926834
• MDR Text Key: 218908301
• Report Number: 2210968-2020-09466
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031237339
• UDI-Public: 10705031237339
• Combination Product (y/n): N
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CLR222
• Device Catalogue Number: CLR222
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR