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

Catalog Number CLR222US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Skin Irritation (2076); 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. Additional information was requested and the following was obtained: what was the name of the procedure? -total knee or total hip. Please describe how was the adhesive applied on the tape? - technique applied says she used about a quarter of the liquid and sometime she would rub/ spread it in with her finger. Is the patient hypersensitive to pressure sensitive adhesives?-unknown is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? - no. Were any patch or sensitivity tests performed? - they do not do that. Do you have the lot number involved? -no. What is the physicians opinion of the contributing factors to the rash/ blister? - unknown. Patient demographics: initials / id; age or date of birth; bmi; gender? - no. Patient pre-existing medical conditions (ie. Allergies, history of reactions)? -no. What is the most current patient status? patient may have been seen at their 6 week appointment and it was cleared up. Is the product or representative sample (product from the same lot number) available for evaluation? -no.

Event Description

It was reported that a patient underwent a total knee or total hip surgery on an unknown date and topical skin adhesive was used. The patient had a sensitivity issue with the topical skin adhesive and had a rash and some blistering. The patient may have been sent to dermatology. The reaction occurred within the first two weeks post op of surgery. The patient was prescribed benadryl and a steroid creme for topical use. The patient may have had the topical skin adhesive used on both sides of their body, at different times. The first time for one leg with no reaction and then the following procedure for the other leg there is a reaction to the topical skin adhesive. When the topical skin adhesive is put on they flex the knee. The skin is prepped prior to incision with chlorapep and the drape is ioban on the knee and that is washed off prior to topical skin adhesive application. After surgery when the topical skin adhesive is dry cast padding and then an ace wrap for knee is used. The facility is no longer using the topical skin adhesive. Additional information has been requested.

• 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 PR; road 183, km. 8.3; san lorenzo PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8127456
• MDR Text Key: 129152334
• Report Number: 2210968-2018-77466
• 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

• Type of Report: Initial
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/03/2018 Patient Sequence Number: 1