MAUDE Adverse Event Report: ETHICON INC. DERMABOND UNKNOWN PRODUCT; ADHESIVE, TOPICAL SKIN

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

Patient Problems Headache (1880); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Itching Sensation (1943); Rash (2033); Burning Sensation (2146); Urticaria (2278); Fluid Discharge (2686); Blister (4537); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 01/28/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information: component code: g07002 - device not returned.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Is a photo available of the patient reaction? if in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? no device is available for return.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.

Event Description

It was reported a patient underwent an implanting of a cardiac loop monitor procedure on (b)(6) 2023 and topical skin adhesive was used.Post op, the patient presented with a severe site reaction to the adhesive, a localized area of four inches by four inches that was dark bright red with swelling, itching, stinging and which progressed to then systemic hives on her arms and face then she presented with a rash on her entire chest.After two weeks is beginning to blister.Patient also experienced severer headaches for two weeks, red itching eyes, and swelling of the lips.Patient is taking a medrol dose pack which patient has resisted taking and has not yet started.The wound has been weeping a clear liquid the entire time, burning, stinging, red.Patient stated that after eating creates a flare up of her symptoms.Adhesive was removed after seven days.Patient first thought the adhesive was a bloody scab till she noticed it was "glossy".Patient removed the adhesive by soaking the area in water.Patient stated that the adhesive was not applied in thin layers but as a blob about the size of a quarter.Additional information has been requested.

• Brand Name: DERMABOND UNKNOWN PRODUCT
• Type of Device: ADHESIVE, TOPICAL SKIN
• 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 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16460529
• MDR Text Key: 310434690
• Report Number: 2210968-2023-01398
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2023
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention