MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

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

Patient Problems Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Pain (1994); Paresis (1998); Pneumonia (2011); Seroma (2069); Hernia (2240); Discomfort (2330)

Event Date 09/12/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts are being made to clarify 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.Does the surgeon believe that any of the ethicon products (prolene polypropylene mesh or pds ii polydioxanone suture) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe that any of the ethicon products (prolene polypropylene mesh or pds ii polydioxanone suture) involved caused and/or contributed to the sepsis and death described in the article? was a cause of death reported within the medical record or described in an autopsy report? does the surgeon believe there was any deficiency with any of the ethicon products (prolene polypropylene mesh or pds ii polydioxanone suture) used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Would the surgeon like to speak with ethicon medical safety and engineering via scheduled conference call regarding the product involved in this event? patient demographics? (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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Serious injury events related pds loop suture captured via 2210968-2021-03811.Events of sepsis/death related to prolene mesh captured via 2210968-2021-03812.Events of sepsis/death related pds loop suture captured via 2210968-2021-03813.Citation: https://doi.Org/10.1007/s10029-020-02300-9.

Event Description

Title: a new three-step hybrid approach is a safe procedure for incisional hernia: early experiences with a single centre retrospective cohort.This retrospective observational study aimed to evaluate first perioperative outcomes with this technique.From 2016 to 2020, 70 patients (n=46 females (65.7%); n=24 males 34.3%) with an incisional hernia of > 2 and = 10 underwent a elective three-step incisional hybrid repair in two non-academic hospitals performed by two surgeons specialised in abdominal wall surgery.The ventralight st mesh was used in most cases (45.7%), next to the prolene mesh (ethicon) (18.6%).In case of an echo positioning system was used, the mesh was put in through the incision and the posterior rectus fascia was closed with pds (polydiaxone) ethicon loop sutures.The mean operation time was 100.4 min with a standard deviation of 44.8 min.Los was 3.3 days, with a standard deviation of 3.0 days.Postoperative complications included hospital acquired pneumonia (n=2), hypotension (n=2), seroma (n=2), surgical site infection (n=1), gastroparesis (n=1), low haemoglobin (n=1), respirator insufficiency (n=2), problems with intake (n=1), prolonged pain requiring analgesia (n=4), haematoma (n=1), abdominal sepsis after the operation and deceased after 15 days (n=1), postoperative discomfort 1 moth after surgery (n=?) and hernia recurrence (n=4).Patients who developed hypotension, which had to be managed at the icu for one night has both recovered after administration of antiarrhythmic medication.Postoperative pain medication was paracetamol and nonsteroidal anti-inflammatory drugs (nsaid).Additional analgesia (i.E., opioids) was given after discharge of the patient for 1 week.The incidence of intraoperative complications was low (7.0%) and most postoperative complications did not seem to have a relationship with the procedure itself.Therefore, the three-step tihr appears to be a safe procedure.In conclusion, the hybrid approach in case of incisional hernia with a three-step procedure as used in this study is a feasible, safe and easy to incorporate surgical approach.The intraoperative complication rate was low and postoperative complications did not seem to be related to the surgical procedure.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo ; *
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11731330
• MDR Text Key: 263945947
• Report Number: 2210968-2021-03810
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• 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: 03/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention