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

Model Number CLR222

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint#: (b)(4).(b)(4).A manufacturing record evaluation was performed for the finished device batch mkq134, clr222 and no non-conformances were identified.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 were there any markings on the labeling to not use on patients? the label not for sale on the prineo.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? profilactin.Antibiotic: cefuroxime 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# 2210968-2020-07688.

Event Description

It was reported a patient underwent a knee arthroplasty surgery on (b)(6) 2020, and topical skin adhesive with mesh was used.The label not for sale was reported to be on the package.A product sample from a practical workshop was used on the patient.Additional information was 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; road 183, km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10739996
• MDR Text Key: 213193825
• Report Number: 2210968-2020-07689
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031237339
• UDI-Public: 10705031237339
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 10/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR