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 Unspecified Infection (1930); Not Applicable (3189); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4). Date sent to fda: (b)(4) 2018. Additional information was requested and the following was obtained: initial procedure date: unknown what was the angle of the knee during application? full flexion please describe how was the adhesive applied on the tape 1 coating what prep was used prior to, during or after prineo use? duraprep and ioban was a dressing placed over the incision? if so, what type of cover dressing used? no was there any infection reported? no if yes, was the site cultured? if so, what bacteria were identified? please provide photos (if not provided) photos already provided is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown. Is the patient hypersensitive to pressure sensitive adhesives? unknown. Were any patch or sensitivity tests performed? unknown. Do you have the lot number involved ? no. What is the physicians opinion of the contributing factors to the event? surgeon thinks it¿s a mechanical issue with the tape. What is the most current patient status? unknown. Is the product or representative sample (product from the same lot number) available for evaluation? no patient demographics: initials / id; age or date of birth; bmi ; gender unknown. Patient pre-existing medical conditions (ie. Allergies, history of reactions) unknown. For female patients ask: was the patient exposed to similar products, such as artificial nails was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? unknown.

Manufacturer Narrative

Product complaint # pc-000083300 additional patient code: (b)(4) - infection additional information was requested and the following was obtained: the doctor reported that the procedure was performed with 60 degree knee flexion and an aggressive motion protocol was used. It was also reported that the patient possibly developed a deep infection relating to the blistering.

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. Initial procedure date. What was the angle of the knee during application? please describe how was the adhesive applied on the tape. What prep was used prior to, during or after prineo use? was a dressing placed over the incision? if so, what type of cover dressing used? was there any infection reported? if yes, was the site cultured? if so, what bacteria were identified? please provide photos (if not provided). 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? do you have the lot number involved ? what is the physicians opinion of the contributing factors to the event? 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 (ie. Allergies, history of reactions). For female patients ask: was the patient exposed to similar products, such as artificial nails? was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure?.

Event Description

It was reported that a patient underwent a knee surgery on an unknown date and topical skin adhesive was used. The skin adhesive was placed over the knee incision. Skin blister developed around the topical skin adhesive dressing on post-op days 2-4. The patient was seen in office where physician assistant aspirated fluid from blister with a needle. The patients blister was then treated with silvadene. 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 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: 7139666
• MDR Text Key: 105639260
• Report Number: 2210968-2017-71904
• 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,Followup,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• 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?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/21/2017 Patient Sequence Number: 1