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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM SKIN CLOSURE SURGICAL SEALANT

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ETHICON INC. DERMABOND PRINEO 22CM SKIN CLOSURE SURGICAL SEALANT Back to Search Results
Catalog Number CLR222US
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 06/01/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Additional information was requested however no response has been received to date: please explain quantity involved 2? were there 2 patient events? initial procedure date. 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? was the site cultured? if so, what bacteria were identified? what is the physicians opinion of the contributing factors to the infection? what is the most current patient status? how was the patient treated? what medical / surgical interventions were performed? did the patient have a pre-existing infection? patient pre-existing medical conditions (ie. History of infections). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
It was reported a patient underwent an double hip surgery on an unknown date in (b)(6) 2019 and topical skin adhesive was used. Two months after the surgery, the patient returned to the hospital with pain on an unknown date in (b)(6) 2019. It was suspected the patient had a surgical site infection, result of the water was in hip. The conclusion from the mri was that the infection was judged to be from outside to inside by patient's skin, and that there was no cause of surgical site infection in the surgery room. The conclusion by hospital is that adhesive is suspected to be the cause. Infection was treated after returning to hospital. Additional information has been requested.
 
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Brand NameDERMABOND PRINEO 22CM SKIN CLOSURE
Type of DeviceSURGICAL SEALANT
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
road 183, km. 8.3
san lorenzo 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8799972
MDR Text Key151351804
Report Number2210968-2019-84414
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K133864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR222US
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 Received08/07/2019
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: 07/17/2019 Patient Sequence Number: 1
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