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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT SURGICAL SEALANT

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ETHICON INC. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT SURGICAL SEALANT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Rash (2033); Unspecified Tissue Injury (4559)
Event Date 11/01/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Additional information has been requested however not received. If further details are received at a later date a supplemental medwatch will be sent. Please address the questions below to aide in our complaint investigation: what product code of prineo was used? lot number? are any photos of the patient reaction available? date of reaction? please describe how 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: age or date of birth; bmi patient pre-existing medical conditions (ie. Allergies, history of reactions)? 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 to return. This medwatch report is in response to receipt of a voluntary medwatch: mw5101164.
 
Event Description
It was reported a patient underwent a subcutaneous mastectomy on (b)(6) 2020 and topical skin adhesive was used. On an unknown date in 2020, patient developed a papular, erythematous, pruritic rash that involved the entire extent of the wound. Because of persistent pruritus and resultant itching and scratching, the right nipple graft was displaced on postoperative day 12 (2020). The right nipple was sutured to the wound by surgeon, the day of the event, with preservation of vascular supply. The wounds healed well with no further complications. No device will be returned. Additional information has been requested.
 
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Brand NamePRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
Type of DeviceSURGICAL 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 Key12094942
MDR Text Key264943607
Report Number2210968-2021-05955
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082289
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received07/14/2021
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: 06/30/2021 Patient Sequence Number: 1
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