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 Wound Dehiscence (1154); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Local Reaction (2035); Fluid Discharge (2686); Skin Inflammation/ Irritation (4545)

Event Date 09/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4). Device not returned. Additional information has been requested and obtained. If further details are received at a later date a supplemental medwatch will be sent. Do you have a photo of your reaction? yes. Please provide the confirm the date of surgery was (b)(6) 2021. Date of surgery (b)(6) 2021. Was any surgical intervention provided, please describe? no surgical intervention for reaction. Product removed w/txn with steroid cream clobetasol propionate. 05% around wound. Were you treated with prescription medications (not over the counter) please describe? claritin redi tabs purchased otc 1 qd prescribed of no benefit and stopped after 3 days. Steroid ointment rx clobetasol propionate. 05% applied around wound after dermabond prineo was removed additional information was requested however not received. If further details are received at a later date a supplemental medwatch will be sent. What medical and/or surgical intervention was performed to address the wound dehiscence and /or reaction? please describe how was the adhesive was applied? please describe how was the adhesive was applied. 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? 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? patient demographics: id, age or date of birth; bmi. 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? do you have the product code and/or lot number used? current patient status. No product is available for return. 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 total hip replacement on (b)(6) 2021 and topical skin adhesive was used. Twenty-four hours after patient developed irritation, redness and itching on the wound where the product was applied. There is also a yellow substance draining out of the wound. The area above the wound all the way up to the patients breast is splotchy. The patient is taking claritin to help with the symptoms. Product removed with steroid cream clobetasol propionate. 05% around wound. Also, there is some bleeding coming from partially open spots on the wound. Additional information has been requested.

• 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; road 183, km. 8.3; san lorenzo 00754 ; 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12656695
• MDR Text Key: 277171377
• Report Number: 2210968-2021-09895
• 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: consumer

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: CLR222US
• 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: 09/24/2021
• 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: 10/19/2021 Patient Sequence Number: 1