MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO HERNIA PLUG UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Catalog Number ULTRAPLUGUNK

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

Patient Problems Hematoma (1884); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4) 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.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 ethicon product (ultrapro hernia plug) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon product involved?.

Event Description

It was reported in a journal article with title: one case where it was difficult to treat a hematoma following inguinal hernia surgery.This is a case report concerning a (b)(6) year old, male patient who was admitted for surgery after repeatedly experiencing incarceration of the right inguinal hernia.The patient had a right external inguinal hernia (hernial orifice 8 mm, i-1).A hernioplasty was performed using an ultrapro plug (ethicon) to allow the peritoneal cavity to be peeled back in a narrow manner to allow for reversal.There was little bleeding that occurred during the surgery, and the surgery ended after achieving adequate hemostasis without placing a drain.Gauze was pressed against the post-operative wound.Reported complications included swelling of the right scrotum and hematoma at the wound which was observed on 2 postoperative day (pod).The hematoma gradually became more severe and the scrotum swelled to 20 cm.On 13 pod, incisions were made on the scrotum and inguinal region, which resulted in the discharge of a large amount of coagulation.A penrose drain was placed to perform drainage.The scrotum swelling gradually improved with the drainage, where after the patient was discharged on 55 pod.In conclusion, the authors reported their experience with one case where it was difficult to treat hematoma following an inguinal hernia surgery but improvement was achieved with a drainage technique.

Manufacturer Narrative

Product complaint #(b)(4).Date sent to the fda: 12/02/2020.The following information was requested, but unavailable: were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon product (ultrapro hernia plug) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon product involved? 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, 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: ULTRAPRO HERNIA PLUG UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10766695
• MDR Text Key: 214739492
• Report Number: 2210968-2020-08509
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K070224
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ULTRAPLUGUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR