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

Catalog Number CLR222US

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information: the actual device batch number associated with this event is not known.The possible batch numbers are reported as follows: batch lhh607; batch ldh420; batch lbg800.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.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 is the initial procedure date? procedure name how was the device applied to the incision what layer of tissue and how many layers applied what prep was used prior to product application? what was the location and incision size of the application? was a dressing placed over the incision? if so, what type of cover dressing used? what date did the reaction occur on? what does the reaction look like and how large of an area does the reaction cover? do you have any pictures of the reaction? was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.Can you identify the product code and lot number of the product that was used? three (3) lot numbers were reported (lhh607; ldh4202; lbg800), were all these used in all procedures? or are these possible lot numbers? ldh4202 is an invalid lot number, please provide the correct lot.Will any device be returned for evaluation? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? were the patients exposed to similar products, such as artificial nails? what is the most current patient status? patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i.E.Allergies, history of reactions) was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure?.

Event Description

As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.Complaint information is trended on a regular basis to determine if further investigation is warranted.

Manufacturer Narrative

Pc(b)(4).Date sent to fda: (b)(6)2018.The actual device batch number associated with this event is not known.The possible batch numbers are reported as follows: batch lot lhh607 - mfg.Date - 7/27/2017; exp.Date - 6/6/2019 batch ldh420 - mfg.Date - 4/21/2017; exp.Date - 3/20/2019 batch lbh800 - mfg.Date - 2/20/2017 ; exp.Date - 1/15/2019.In addition, a review of the batch manufacturing records for the possible batch numbers was conducted and the batches met all finished goods release criteria.Additional information was requested and the following was obtained: procedure name ¿ product was used on mastopexy procedures only what date did the reaction occur on? reaction occurred after a few days, some reactions occurred right after removal.Was there any medical or surgical intervention performed - product removal and patient treated with antibiotics is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no allergies do you have any patient specific information ¿ no the events were occurring over a few months any photos ¿ not available can you identify the product code and lot number of the product that was used on each patient? it is unknown which lot numbers were used on each patient.

• 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 08876 0151
• Manufacturer (Section G): ETHICON INC. SAN LORENZO; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7206574
• MDR Text Key: 97775527
• Report Number: 2210968-2018-70350
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• 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: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• 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
• Date Manufacturer Received: 01/25/2018
• 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