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 Problems Wound Dehiscence (1154); Tissue Damage (2104)

Event Date 06/20/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Attempts to obtain the information have been made and received.The device is not received to date.If the further details are received at a later date a supplemental medwatch will be sent.Was the doctor told not to use the sample, prineo: clr222/lot: mqk134 on the patient? yes.Were there any markings on the labeling to not use on patients? the label not for sale on the prineo.It was noted an antibiotic was prescribed, was there any other medical or surgical treatment provided to address the blister and /or wound dehiscence? profilactic antibiotic: cefuroxima 500mg every 12 hours.Please describe how was the adhesive was applied.The following information need to be discussed with the doctor: what prep was used prior to, during or after prineo use? the following information need to be discussed with the doctor: was a dressing placed over the incision? if so, what type of cover dressing used? the following information need to be discussed with the doctor: what tissue dehisced? the following information need to be discussed with the doctor: was there any deficiency of the 2 stratafix sutures? if yes, please describe.No.On what tissue layers were the 2 stratafix sutures used? fascia and dermis.What was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? the following information need to be discussed with the doctor: can you describe the appearance of the stratafix suture upon noting the dehiscence? no issues with stratafix.Other relevant patient history/concomitant medications: no.If applicable, will product be returned, return date, tracking information: no.What is the patient¿s current status? she´s ok.What is physician¿s opinion as to the etiology of or contributing factors to this event? the doctor said that the patient history of smoking can be a factor.Note: events reported on mw# 2210968-2020-07689.

Event Description

It was reported a patient underwent a knee arthroplasty surgery on (b)(6) 2020 and topical skin adhesive with mesh was used.A product sample from a practical workshop was used on the patient.The patient had wound dehisence and blistering.Treatment to patient: prophylaxis, antibiotics: cefuroxime 500 mg every 12 hours.Current status of the patient is 90% epithelialization of dehiscence by second intention.No inflammation and infection.Additional information was requested.

Manufacturer Narrative

Product complaint #: (b)(4).Date sent to the fda: 10/28/2020.A manufacturing record evaluation was performed for the finished device batch 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 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: 10637247
• MDR Text Key: 210696523
• Report Number: 2210968-2020-07688
• 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: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: CLR222
• Device Catalogue Number: CLR222
• Device Lot Number: MKQ134
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR