MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM SKIN CLOSURE; SURGICAL SEALANT

Catalog Number CLR222US

Device Problem Material Integrity Problem (2978)

Patient Problems Wound Dehiscence (1154); Fever (1858); Unspecified Infection (1930); Not Applicable (3189); No Code Available (3191)

Event Date 06/13/2018

Event Type  Injury  

Manufacturer Narrative

(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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What tissue layer was each suture used? what is meant by the suture line appears to be compromised? what product had the suture line compromised? results of culture taken? what bacteria were identified? what medical or surgical interventions were performed? 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? what is the physicians opinion of the contributing factors to the event? what is the most current patient status? lot number of sutures and prineo involved is the product or representative sample (product from the same lot number) available for evaluation? patient demographics: initials / id; age or date of birth; bmi ; gender.Patient pre-existing medical conditions.

Event Description

It was reported that a patient underwent a revision total knee arthroscopy poly swap procedure on (b)(6) 2018 and topical skin adhesive was used to close the incision.The patient reported clear and yellow drainage through (b)(6) 2018.The patient returned to office and the physician assistant noticed edges still everted, slightly red and some yellow and clear drainage.On (b)(6) 2018, the patient went on a walk and the knee felt the best in two years.That same day, the patient came down with a fever of 102 degrees and knee became very stiff.Evaluated medications and the fever broke with ibuprofen.On (b)(6) 2018, the patient returned for a knee washout and cultures.The culture was taken from the skin all the way through joint capsule.The doctor opened the knee and noticed a soupy appearance and suture line appeared to be compromised.The patient had a normal weight and no additional co-morbidities.Additional information has been requested.

Manufacturer Narrative

Product complaint #
=
> pc-000215055 date sent to fda: 8/2/2018 additional information: 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: what tissue layer was each suture used? stratafix symmetric suture, vicryl suture, spiral monocryl and dermabond prineo were used to close the incision.What is meant by the suture line appears to be compromised? all layers dehisced what product had the suture line compromised? failure at all levels results of culture taken? what bacteria were identified? enterococcus what medical or surgical interventions were performed? iv antibiotics / i & d with poly swap / two wash outs what prep was used prior to, during or after prineo use? cleansed with saline and dried prior to application was a dressing placed over the incision? if so, what type of cover dressing used? sterile 4x4 gauze, sterile waffle roll, and sterile double ace wrap what is the physicians opinion of the contributing factors to the event? hospital has been having issues with high infection rates, have not had this issue at the other location they go to / wife has ibs-d potential for patients¿ skin to be colonized with bacteria what is the most current patient status? (b)(6) ¿ cancelled appointments (b)(6) ¿ nothing since last i&d ¿ refused last home health appointment lot number of sutures and prineo involved ¿ n/a patient demographics: initials / id; age or date of birth; bmi ; gender: male (55 years old) / bmi 25.9 patient pre-existing medical conditions: hypertension + high cholesterol.

• Brand Name: DERMABOND PRINEO 22CM SKIN CLOSURE
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC. SAN LORENZO; 982 road 183 km 8.3; san lorenzo
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7652898
• MDR Text Key: 112845181
• Report Number: 2210968-2018-73950
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 08/02/2018
• Supplement Dates FDA Received: 08/02/2018
• 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 Age: 55 YR