MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM; SURGICAL SEALANT

Catalog Number CLR222US

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Discharge (2225); Blood Loss (2597); No Code Available (3191)

Event Date 08/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: what is meant by the product was kept intact by physician? please describe what medical or surgical interventions were performed? - physician kept prineo on and intact.He did not mess or remove the product from the patient.The blistering was at one end only and was some outside of prineo, halfway under prineo.The bleeding at the other end was unknown.What is the most current patient status? patient is the same as of yesterday not any better or worse.Prineo still in tact.Do you have any pictures of the reaction? no picture taken.What is the physicians opinion of the contributing factors to the reaction? doctor doesn't know what the blisters would be from, but did mention this patient has several different factors going on so it be related to something else 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 was the source of bleeding? how were the blood clots treated? was the prineo removed? was another method used to close the incision? what prep was used prior to prineo use? was the prep allowed to dry prior to prineo mesh application? please describe how the adhesive was applied on the tape? when applying are they completely covering the edge of the mesh with prineo? was incision re-prepped before closure? if so, with what? if so, was the prep allowed to dry? was the skin prep solution wiped off and allowed to dry before applying adhesive? was a dressing placed over the incision? if so, what type of cover dressing used? did the skin reaction extend beyond the borders of the tape what was done to address the reaction? what type of medication? dose? when (date) administered? was the site cultured? if so, what bacteria were identified? 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? lot number 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 (ie.Allergies, history of reactions).For female patients : was the patient exposed to similar products, such as artificial nails.Was prineo used on the patient in a previous surgery or wound closure?.

Event Description

It was reported that the patient underwent a right total knee surgical procedure on (b)(6) 2016 and the topical skin adhesive was used and applied in full flexion.On (b)(6) 2016, the patient experienced large yellow blisters at the distal end of the topical skin adhesive dressing; half were under the topical skin adhesive and some outside of the dressing.The proximal end of the dressing had no blistering, but some bleeding and oozing occurred from the incision on to the topical skin adhesive.It was noticed that the patient has two blood clots; one is behind the knee.It was also reported that the patient was being observed post-operatively and the doctor did not mess or remove the topical skin adhesive from the patient.Currently, the patient is the same as of yesterday, not any better or worse.The doctor opined that there is no redness around topical skin adhesive and it is not an allergic reaction since the blistering isolated.The doctor does not know what the blisters would be from, but mentioned that this patient has several different factors going on and it could be related to something else.Additional information has been requested.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM
• 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 PR; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 5949314
• MDR Text Key: 54670061
• Report Number: 2210968-2016-13597
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/25/2016

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?: No
• Initial Date Manufacturer Received: 08/25/2016
• Initial Date FDA Received: 09/14/2016
• 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