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

Catalog Number CLR222

Device Problem Compatibility Problem (2960)

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

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 do you have any photos? what was the angle of the knee during application? was tension reviewed before applying the mesh? procedure date date that blistering was noticed? what prep was used prior to prineo use? please describe how the adhesive was applied on the tape? was the dermabond liquid adhesive placed to cover the entire length of the mesh? did the prineo mesh extend beyond the patient incision? 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? what does the reaction look like? please provide details.What type of medication? dose? when (date) administered? was the product removed? was another method used to close the incision? is the patient hypersensitive to pressure sensitive adhesives? lot number involved what is the physicians opinion of the contributing factors to the blistering ? what is the most current patient status? 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 knee arthroplasty procedure and topical skin adhesive was used.Post operatively the patient presented with blisters below the knee in the upper shin area.Blisters were the size of 10 cent pieces and were drained by needle aspiration.Additional information has been requested.

Manufacturer Narrative

Product complaint #
=
> (b)(4).Additional information received that indicates this event does not meet reporting serious injury criteria.This event therefore is not reportable.Corrected patient codes: (b)(4) - blistering additional information was requested and the following was obtained: the blisters were small pimple like blisters at the distal tip of the mesh below the knee.The patient did not require drainage.The patient did not have infection.It is unknown if the patient had any allergies.Do you have any photos? no.What type of medication? none required.Is the product or representative sample (product from the same lot number) available for evaluation? no.

• Brand Name: DERMABOND PRINEO 22CM
• 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 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7730206
• MDR Text Key: 115351333
• Report Number: 2210968-2018-74715
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031237339
• UDI-Public: 10705031237339
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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,Followup
• Report Date: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: CLR222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention