MAUDE Adverse Event Report: ETHICON INC. DERMABOND UNKNOWN PRODUCT; ADHESIVE, TOPICAL SKIN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 05/05/2022

Event Type  Injury  

Event Description

It was reported via journal article: title: a modified approach for ultrasound-guided thoracic paravertebral block via thoracic intervertebral foramen in an adolescent patient: a case report the objective of this study is to performed a bilateral continuous thoracic intervertebral foramen (tif) block, providing opioidfree anesthesia and postoperative analgesia for emergent laparotomy (el) due to a small intestinal volvulus.On 12 october 2021, a 17 year-old male who had emergent laparotomy (el) for a small intestinal volvulus associated with bowel obstruction and ischemia.The patient was 165 cm tall and weighed 70 kg (bmi was 25.71).Postoperative pain was 2 at rest, and it was 4 in motion, without neurological or respiratory sequelae in the first 72 h after surgery due to execution of the block.The catheters were inserted from the caudal in the cephalic direction and were secured using a cyanoacrylate tissue adhesive (dermabond, ethicon, somerville, nj, usa) and two layers of a transparent adhesive dressing to prevent retrograde leakage.Reported complication includes postoperative pain (n=1).In conclusion, based on our clinical observations, we are confident that use of the thoracic intervertebral foramen (tif) block could be considered an effective alternative to thoracic paravertebral block (tpvb) and to other paraspinal anesthetic procedures, as an opioid-sparing strategy, for fast-track recovery after pediatric abdominal surgeries.Our case report provides important evidence for future randomized clinical trials.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6 component code: g07002 ¿ device not returned.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that any of the ethicon products involved/dermabond unknown caused and/or contributed to the post-operative complications described in the article: pain, medication required? does the surgeon believe there was any deficiency with any of the ethicon products used/dermabond unknown in this procedure? if so, please provide details.Which specific ethicon products have been used during the procedures (dermabond product code, lot number)? this report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.Citation: j.Clin.Med.2022, 11, 2646 https://doi.Org/10.3390/jcm11092646 this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: DERMABOND UNKNOWN PRODUCT
• Type of Device: ADHESIVE, TOPICAL SKIN
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18619208
• MDR Text Key: 334258085
• Report Number: 2210968-2024-00850
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K100423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2024
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR
• Patient Sex: Male
• Patient Weight: 70 KG