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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 Hypersensitivity/Allergic reaction (1907); Rash (2033); Skin Inflammation/ Irritation (4545)
Event Date 12/06/2021
Event Type  Injury  
Event Description
It was reported a patient underwent an unknown procedure on (b)(6) 2021 and topical skin adhesive was used. Patient had an aggressive allergic reaction to adhesive. Patient was re-admitted and put on oral corticosteroids to manage the severe allergic reaction. Patch testing was conducted on an area away from the wound site which produced an aggressive ,florid and relatively quick reaction to the dressing even within 24 hours. Wounds not infected highly irritated rash associated with the dressing. Additional information has been requested.
 
Manufacturer Narrative
Product complaint # (b)(4). Additional information: in the last 4 to 6 weeks several patients have had an aggressive allergic reaction to the prineo 42 dressing. Wounds not infected highly irritated rash associated with the dressing. A number of patients were re-admitted an put on oral corticosteroids to manage the severe allergic reaction. Patch testing was conducted on an area away from the wound site which produced an aggressive ,florid and relatively quick reaction to the dressing even within 24 hours. This reaction has occurred in a number of patients recently. The incidence is not high we estimate around (b)(4) in the last month. We have not commonly observed this reaction in the past. Did the patient experience a post-op device malfunction? unknown, did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? yes, did the patient require revision surgery or hardware removal? no, if no, was there any additional medical intervention required such as x-rays, additional procedures, prescriptions?oral corticosteroids for severe allergic reaction , patient status/ outcome / consequences yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc. )? allergic reaction, was other medical intervention (e. G. X-rays, additional procedures, prescriptions, otc, revision) required: yes, if yes, describe admission to hospital with oral corticosteroids, is the patient part of a clinical study unknown. Additional information has been requested however not received to date. If further details are received at a later date a supplemental medwatch will be sent. How many patients were reported with reaction? please advise of the following information about each patient event: procedure name? procedure date? what was the date of the reaction, day post op? is a photo of the reaction available (label reference number for patient as needed) please describe how was the adhesive was applied. What prep was used prior to, during or after adhesive 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: initials / id, gender, age or date of birth; bmi patient pre-existing medical conditions (ie. Allergies, history of reactions) has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? current patient status. A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified. No product is available for return. The single complaint was reported with multiple events. There are no additional details regarding the additional events. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
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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 Key13238237
MDR Text Key288885751
Report Number2210968-2022-00349
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 01/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR422
Device Lot NumberRHBCKT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/15/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/12/2022 Patient Sequence Number: 1
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