MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST MESH; SURGICAL MESH

Catalog Number	5954124
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	04/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Per journal article, hemipelvectomy hernia: case series and literature review.Abstract purpose: hemipelvectomy is a major operation in which significant portions of the pelvic girdle and lower extremity are resected.The development of hernia following hemipelvectomy is a complex surgical challenge with limited published guidelines for management.Conclusion: hernia in the setting of hemipelvectomy is an infrequently reported problem.General principles in management are similar to all hernia repairs and include local approximation of tissues avoidance of contamination or wound infection and use of prosthetic mesh when local tissue is inadequate for a tension-free repair.A 46-year-old male patient underwent hernia repair 3 years after initial hemipelvectomy.A 34 × 30 cm ventralight st mesh was secured in the pre-peritoneal space to the bone anchors as well as to cooper¿s ligament and the pubic tubercle.The patient did well following surgery.A small seroma was noted 2 months post-operatively.The seroma was asymptomatic, and no medical/surgical intervention identified.The patient ultimately passed away from hypoxic respiratory failure believed to be from progression of metastatic disease (unrelated to the ventralight st mesh used to treat hernia).Case/patient specific details were not included to identify the actual product identifiers.
Additional Manufacturer Narrative
Based on the information available, no conclusions can be made.Seroma is listed as a possible complication in the adverse reactions section of the instructions-for-use, supplied with the device.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event is considered to be a best estimate as (b)(6) 2020 based on information available.

• Brand Name: VENTRALIGHT ST MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 16252587
• Report Number: 1213643-2023-00027
• Device Sequence Number: 12112480
• Product Code: FTL
• UDI-Device Identifier: 00801741031601
• UDI-Public: (01)00801741031601
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 5954124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male