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

Catalog Number	5954600
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Bruise/Contusion (1754)
Date of Event	09/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made as the degree to which the device used to treat the patient may have caused or contributed to the post-op complication.Per medical records review, a couple of months post implant the patient experienced pain and bruising thereby underwent pain management.Per surgeon the patient¿s discomfort at the site of hernia repair may be due to chronic pain or related to the patient¿s fibromyalgia condition.The adverse reactions section of the instructions-for-use supplied with the device lists pain as a possible complication.To date, this is the only reported complaint for the reported lot.This mdr represents the ventralight st mesh (device #1).Additional supplemental mdr to represent the capsure (device #2) and mdr to represent the capsure (device #3) were submitted.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
Per information provided by patient's attorney: on (b)(6) 2018 - patient was diagnosed with incisional hernia thereby underwent laparoscopic repair with implant of ventralight st mesh (device #1).Per operative notes, ¿ports were inserted in epigastric area and right iliac fossa.Omentum was removed from hernia sac.A ventralight st mesh (device #1) was positioned over the hernia defect using sutures.The mesh was fixed in place using a double crown of capsure (device #2 & #3) fasteners.¿ on (b)(6) 2018 to (b)(6) 2022 - during visits patient had pain, discomfort, slight bulge and bruising at the site of laparoscopic hernia repair thereby underwent pain management.Surgeon felt that the patient¿s discomfort at the site of hernia repair was either due to chronic pain or related to the patient¿s fibromyalgia condition.This file represents ventralight st mesh (device #1).

• 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: 20083991
• Report Number: 1213643-2024-00427
• Device Sequence Number: 7561649
• Product Code: FTL
• UDI-Device Identifier: 00801741031632
• UDI-Public: (01)00801741031632(17)191228(10)HUBZ0396
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2024

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 Expiration Date: 12/28/2019
• Device Catalogue Number: 5954600
• Device Lot Number: HUBZ0396
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 45 YR
• Patient Sex: Female
• Patient Weight: 80 KG