MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO; SURGICAL SEALANT

Catalog Number CLR222US

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The actual device batch number associated with this event is not known.The possible batch numbers are reported as follows: batch (b)(4), mfg.Date - 06/13/2017; exp.Date - 05/07/2019.Batch (b)(4), mfg.Date ¿ 07/27/2017; exp.Date - 6/26/2019.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.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported that the patient underwent a knee surgery on an unknown date and topical skin adhesive was used.Post operatively, the topical skin adhesive did not adhere properly and the patient returned for a wash out, due to continued oozing.After the wash out the patient was reclosed with suture and topical skin adhesive.All cultures came back negative for bacteria.The patients wound is healing fine.No further information is available.

Manufacturer Narrative

Additional evaluation summary: representative samples were returned for analysis.From the results and observations, it can be concluded that mesh patches evaluated for setting time did not meet the design requirement.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.Did 1 prineo not adhere during the procedure? it is believed the bottom/distal portion did not adhere was a second prineo applied to complete the procedure? no- not the initial procedure please confirm that the second prineo that was applied adhered properly to complete the procedure? correct- once patient came back.The second prineo was adhered.Did the product come off in the post operative time? if yes, please provide timeline yes- day 3 the bottom was not adhered.Please provide additional information on the wound site preparation: what prep was used prior to, during or after prineo use? cloraprep was a dressing placed over the incision? if so, what type of cover dressing used? 4 by 4¿s was the product applied to a wet surface? no was there any application of other topical compounds post product application (ie.Ointments, petroleum jelly and medications)? no patient post op care of the wound / product site? normal- patient went home with prineo post op care information what in the physicians opinion were the contributing factors to the product coming off post operatively? unknown patient demographics: initials/id; age or dob; gender; bmi - unknown update to patient current condition patient doing fine.

• Brand Name: DERMABOND PRINEO
• 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; 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: 7010051
• MDR Text Key: 91352618
• Report Number: 2210968-2017-70824
• 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: Health Professional
• Type of Report: Initial,Followup

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: 10/17/2017
• Initial Date FDA Received: 11/08/2017
• Supplement Dates Manufacturer Received: 11/07/2017
• Supplement Dates FDA Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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