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U.S. Department of Health and Human Services

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

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ETHICON INC. DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE CUTANEOUS TISSUE ADHESIVE WITH MESH Back to Search Results
Catalog Number CLR422
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Local Reaction (2035); Blister (4537)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Additional information has been requested and obtained. Do you have any pictures of the reaction? no. Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription medication? if so, please specify. N/a. If medication was required, please clarify if it was prescribed or purchased over-the-counter. N/a. What is the most current patient status? full recovery. Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? additional information provided by rn: our patients usually wear it for 4-6 weeks post op and may shower with it insitu once their drains are removed. I am pleased to say - all patients are fine now. We have occasionally seen reactions using prineo in the past and a few times - when a patient has had a secondary revisional surgery ( but did not react the first time using prineo) we check our patients frequently after an abdominoplasty at 1 week, 2 weeks, 3 weeks, 6 weeks, 3 months, 6 months, 1 year. They have drains initially, which remain until the drainage is very minimal on each side ie ( less than 10 mis ), then they wear compression tights and a binder for at least 6 weeks post operatively. After prineo is removed, the patients use 1¿ brown micropore tape along the length of the scar until 12 week post op. We have not changed anything in our surgical technique, application of prineo dressing, or post op management during this time, so that is why i contacted you as we were unsure of why these incidents occurred all round the same time. In the past 6 weeks however we have not had any further incidents at all. To avoid pressure though, we have started leaving a little gap at the centre of the abdominal suture line to avoid pressure there. We will watch closely for any further issues. Additional information has been requested however not received. If further details are received at a later date a supplemental medwatch will be sent what date did the reaction occur on? please describe how was the adhesive was applied. What prep was used prior to, during or after prineo use? 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, gender, age or date of birth; bmi. Does the patient use or 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. 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 abdominoplasty on (b)(6) 2021 and topical skin adhesive was used. The patient had a skin reaction with blistering about 3 days post op. Upon removal of adhesive there was small pressure necrosis breakdown of skin. Treated with a sliding scale of prednisolone regime to calm the reaction. Additional information has been requested.
 
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Brand NameDERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE
Type of DeviceCUTANEOUS TISSUE ADHESIVE WITH MESH
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 Key12310363
MDR Text Key266158371
Report Number2210968-2021-07253
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K163645
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR422
Device Lot NumberQMBDQV
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/11/2021 Patient Sequence Number: 1
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