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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 08/26/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Additional information has been requested and received. If further details are received at a later date a supplemental medwatch will be sent. Procedure: hip resurfacing. Date: (b)(6) 2021. Day post op reaction: (b)(6) 2021 (post op day 8). Current status: recovered. Id: nb male (b)(6) nkallergies, hip resurfacing on (b)(6) 2021, reaction: (b)(6) 2021 (8), photo, dressing: ch - to company directions, surgical prep-chlorhexidine 2% (red), dressing-no, mepilex border, nk allergies, sensitivity to adhesive no, yes patch tests, yes previous exposure, yes used prineo/db, recovered. A manufacturing record evaluation was performed for the finished device batch and no non-conformances were identified. No product available for return. Note: events reported on mw# 2210968-2022-01044. 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 hip arthroplasty/resurfacing on (b)(6) 2021 and topical skin adhesive was used. Patient had an allergic reaction to adhesive. Patient had reaction on (b)(6) 2021, post op day 8, and put on oral corticosteroids to manage the severe allergic reaction. Wounds not infected highly irritated rash associated with the dressing. 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
00754
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key13529393
MDR Text Key289316705
Report Number2210968-2022-01043
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
Report Date 02/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2022
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
Date Manufacturer Received01/17/2022
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: 02/14/2022 Patient Sequence Number: 1
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