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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE SURGICAL SEALANT

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ETHICON INC. DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE SURGICAL SEALANT Back to Search Results
Model Number CLR222
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/20/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint#: (b)(4). (b)(4). A manufacturing record evaluation was performed for the finished device batch mkq134, clr222 and no non-conformances were identified. Attempts to obtain the information have been made, and received. The device is not received to date. If the further details are received at a later date, a supplemental medwatch will be sent were there any markings on the labeling to not use on patients? the label not for sale on the prineo. Was the doctor told not to use the sample - prineo: clr222/ lot: mqk134 on the patient? yes. Were there any markings on the labeling to not use on patients? the label not for sale on the prineo. It was noted an antibiotic was prescribed, was there any other medical or surgical treatment provided to address the blister and /or wound dehiscence? profilactin. Antibiotic: cefuroxime 500mg every 12 hours. Please describe how was the adhesive was applied. The following information need to be discussed with the doctor. What prep was used prior to, during or after prineo use? the following information need to be discussed with the doctor. Was a dressing placed over the incision? if so, what type of cover dressing used? the following information need to be discussed with the doctor. What tissue dehisced? the following information need to be discussed with the doctor was there any deficiency of the 2 stratafix sutures? if yes, please describe. No. On what tissue layers were the 2 stratafix sutures used? fascia and dermis. What was the tissue condition, i. E. , normal or thin, calcified, fragile, diseased? the following information need to be discussed with the doctor can you describe the appearance of the stratafix suture upon noting the dehiscence? no issues with stratafix. Other relevant patient history/concomitant medications no. If applicable, will product be returned, return date, tracking information no. What is the patient¿s current status? she´s ok. What is physician¿s opinion as to the etiology of or contributing factors to this event? the doctor said that the patient history of smoking can be a factor. Note: events reported on mw# 2210968-2020-07688.
 
Event Description
It was reported a patient underwent a knee arthroplasty surgery on (b)(6) 2020, and topical skin adhesive with mesh was used. The label not for sale was reported to be on the package. A product sample from a practical workshop was used on the patient. Additional information was requested.
 
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Brand NameDERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE
Type of DeviceSURGICAL SEALANT
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
road 183, km. 8.3
san lorenzo 00754
00754
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key10739996
MDR Text Key213193825
Report Number2210968-2020-07689
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K133864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2020
Device Model NumberCLR222
Device Catalogue NumberCLR222
Device Lot NumberMKQ134
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/24/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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