MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 60CM MSH 3.8ML ADHESIVE SURGICAL SEALANT

Catalog Number CLR602

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4). A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified. Attempts to obtain the following information has been performed but not received. If the further details are received at a later date a supplemental medwatch will be sent were there any adverse consequences to the patient? was medical or surgical intervention, or anesthesia required when reapplying prineo? is the product involved in the event or a representative sample (product from the same lot number) available for evaluation? 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 a circumferential abdominoplasty surgery on (b)(6) 2020 and surgical sealant was used. Post operative day 3, it was necessary to remove the tape and apply another one as it was coming off. Surgeon needed to reapply mesh and adhesive. No patient consequences reported. Additional information was requested.

• Brand Name: DERMABOND PRINEO 60CM MSH 3.8ML ADHESIVE
• Type of Device: SURGICAL 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
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10009448
• MDR Text Key: 190516810
• Report Number: 2210968-2020-03605
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/03/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/31/2021
• Device Catalogue Number: CLR602
• Device Lot Number: PDR725
• 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: 05/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2019
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial