FDA Adverse Event Injury Summary report: N

UNKNOWN PARIETENE MESH PRODUCT

MDR report key: 14552873 · Received May 31, 2022

Report

Report Number: 9615742-2022-00488
Event Type: Injury
Date Received: May 31, 2022
Date of Event: May 8, 2021
Report Date: May 31, 2022
Manufacturer: SOFRADIM PRODUCTION SAS
Product Code: FTL
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

TITLE: ROBOTIC ABDOMINAL WALL REPAIR: ADOPTION AND EARLY OUTCOMES IN A LARGE ACADEMIC MEDICAL CENTER SOURCE: JOURNAL OF ROBOTIC SURGERY (2022) 16:383¿392. HTTPS://DOI.ORG/10.1007/S11701-021-01251-2. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 0

ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY ANALYZED OUTCOMES OF PATIENTS WHO UNDERWENT ROBOTIC-ASSISTED ABDOMINAL WALL REPAIR BETWEEN JULY 2016 AND MARCH 2020. THERE WERE 312 PATIENTS IN THE STUDY OF WHICH 174 WERE INGUINAL HERNIA REPAIRS, AND 138 WERE ABDOMINAL WALL HERNIA REPAIRS. A SELF-FIXATING MESH MESH WAS USED IN 92 PATIENTS, A THREE-DIMENSIONAL MONOFILAMENT POLYESTER WAS USED IN 56, A TRANSPARENT MACROPOROUS POLYPROPYLENE COMPOSITE WAS USED IN 3. POSTOPERATIVE COMPLICATIONS INCLUDED: SEROMA, INFECTION, HEMATOMA, UNCONTROLLED PAIN. READMISSION WAS REQUIRED FOR PAIN CONTROL AND WOUND INFECTION WHILE SEROMAS DID NOT REQUIRE TREATMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2678875	UNKNOWN PARIETENE MESH PRODUCT	MESH, SURGICAL, POLYMERIC	FTL	SOFRADIM PRODUCTION SAS	UNKNOWN PARIETENE MESH PRODUCT

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Other