MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE CUTANEOUS TISSUE ADHESIVE WITH MESH

Model Number CLR422US

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

Patient Problems Skin Irritation (2076); Tissue Damage (2104); Not Applicable (3189)

Event Date 09/01/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4). The following information has been requested and obtained. To date the device has not been received. If the further details are received at a later date a supplemental medwatch will be sent. Please clarify the reason for the post-operative admission to the hospital. Procedure was bilateral tka. Post op admission standard practice. Please describe how was the adhesive was applied. Rep not present for case. Application described as per usual, as per ifu. What prep was used prior to, during or after use? 3m chlorohexidine on both knees as per surgeons usual practice. Was a dressing placed over the incision? if so, what type of cover dressing used? on staples knee with chlorohexidine advanced - bactigras. On perineo knee, no additional dressing was said to have been used. Unsure if both knees were censored in recovery. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? surgeon said patient said no allergies. Is the patient hypersensitive to pressure sensitive adhesives? unknown. Were any patch or sensitivity tests performed? no. Patient demographics: initials / id, gender, age or date of birth; bmi unable to access this information. Patient pre-existing medical conditions (ie. Allergies, history of reactions) unable to access this information. Does the patient use or exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails). Unknown. Current patient status. Stable. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported a patient underwent a bilateral total knee (tka) surgery on (b)(6) 2020 and topical skin adhesive with mesh was used. On one knee, patient experienced skin reaction, redness, blistering and removal of adhesive was required. Tegaderm was used, no further issue. Patient post-operative admission to the hospital. Additional information has been requested.

• Brand Name: DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE
• Type of Device: CUTANEOUS TISSUE ADHESIVE WITH MESH
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754 ; 00754
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10646152
• MDR Text Key: 210401880
• Report Number: 2210968-2020-07765
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K163645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: CLR422US
• Device Catalogue Number: CLR422US
• 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: 09/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 10/07/2020 Patient Sequence Number: 1