MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE; SURGICAL SEALANT

Model Number CLR222US

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

Patient Problems Local Reaction (2035); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 09/16/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information was requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Are any photos available of the reaction? what was the orthopedic procedure performed? what medical and/or surgical intervention or treatment was performed to address the reaction and blistering while hospitalized? how long was the patient hospitalized for the reaction? please describe how was the adhesive was applied? has the patient demonstrated previous hypersensitivity or allergies to cyanoacrylate or formaldehyde? does the patient have allergies to medication, food, etc.? was an allergy test performed? if so, please provide results.What surgical preparation was used prior to, during, or after product use? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? surgeon¿s name? product lot number? has the patient previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? was prineo/dermabond skin adhesive used on the patient in a previous surgery or wound closure? no product is available for return.

Event Description

It was reported a patient underwent an unknown orthopedic surgery on 9/15/2021 and topical skin adhesive was used.On (b)(6) 2021 a wide range of blisters developed on the distal side.After the patch was left as it was, on (b)(6) 2021, redness around the mesh patch and blisters worsened, resulting in extended hospitalization.Further details are not provided.No sample will be returned.

Manufacturer Narrative

Product complaint # (b)(4) additional information: h6 additional information has been requested and obtained.Are any photos available of the reaction? we could get the photos (next day and 2 days post-op).What was the orthopedic procedure performed? total knee arthroplasty.(left knee) what medical and/or surgical intervention or treatment was performed to address the reaction and blistering while hospitalized? 3 days after operation, surgeon tried needling sunction, and the mesh of prineo removal.How long was the patient hospitalized for the reaction? hospitalization period extended by 2 days.Please describe how was the adhesive was applied? no further information is available.Has the patient demonstrated previous hypersensitivity or allergies to cyanoacrylate or formaldehyde? no further information is available.Does the patient have allergies to medication, food, etc.? no further information is available.Was an allergy test performed? if so, please provide results.No further information is available.What surgical preparation was used prior to, during, or after product use? no.Other relevant patient history/concomitant medications? unkonwn what is the physician¿s opinion as to the etiology of or contributing factors to this event? no further information is available.What is the patient's current status? patient has already been discharged.After needle sunction, patient got improved.Surgeon¿s name? (b)(6) product lot number? unknown.Has the patient previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? unknown was prineo/dermabond skin adhesive used on the patient in a previous surgery or wound closure? unknown additional information was requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Please provide photos if available.Is "needling suction" drainage of the blisters? also, as prineo was removed 3 days post op, did the wound require additional closure? if yes, please describe? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6 health effect - impact code.Additional information has been requested and obtained.If further details are received at a later date a supplemental medwatch will be sent.Please provide photos if available.Pictures.Is ""needling suction"" drainage of the blisters? yes.Also, as prineo was removed 3 days post op, did the wound require additional closure? no.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12650471
• MDR Text Key: 283303072
• Report Number: 2210968-2021-09820
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2022

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 Model Number: CLR222US
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/22/2021
• Initial Date FDA Received: 10/18/2021
• Supplement Dates Manufacturer Received: 11/02/2021; 12/09/2021
• Supplement Dates FDA Received: 11/30/2021; 01/04/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female