MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE CUTANEOUS TISSUE ADHESIVE WITH MESH

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.

• Brand Name: DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE
• Type of Device: CUTANEOUS 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 Key: 10733964
• MDR Text Key: 213012750
• Report Number: 2210968-2020-08324
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K163645
• Number of Events Reported: 1
• 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 Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2021
• Device Catalogue Number: CLR422
• Device Lot Number: QDBHZM
• 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 Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2020
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial