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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 Contamination /Decontamination Problem (2895)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/06/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). The following information has been requested and the following was received. To date the device has not been received. If the further details are received at a later date a supplemental medwatch will be sent. Was the primary packaging found damaged? no, only the seal portion is different to normal. Was the mesh exposed? no. Was the sterility of the product compromised? yes, because the mesh was not how it should be, it was sealed into the side of packaging, this could not assure that the product is sterile for use. Are photos available? no.
 
Event Description
It was reported a patient underwent a high anterior resection surgery on (b)(6) 2020 and topical skin adhesive with mesh was used. The mesh was found to be sealed into the side of the packaging prior to surgery. The sample was discarded and opened new package. No sample will be returned. There were no adverse consequences to the patient.
 
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Brand NameDERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE
Type of DeviceCUTANEOUS TISSUE ADHESIVE WITH MESH
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
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key10733964
MDR Text Key213012750
Report Number2210968-2020-08324
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 company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Catalogue NumberCLR422
Device Lot NumberQDBHZM
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 Received01/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/30/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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