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

Catalog Number	5954113
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Insufficient Information (4580)
Date of Event	03/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges unspecified adverse patient outcome associated with the use of hernia mesh.The degree to which the device used to treat the patient may have caused or contributed to a post-op complication is unknown.No lot number has been provided, a review of the manufacturing records is not possible.Note, the date of event is considered to be a best estimate as 10-apr-2024 based on the date of awareness.Should additional information be provided, a supplemental emdr will be 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.H3 other text: device not returned.
Event or Problem Description
Attorney alleges multiple patients he represents have experience unspecified injury and allege they may have required additional medical/surgical treatment.Attorney alleges this patient was treated with a ventralight st.Case-specific details not provided.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges unspecified adverse patient outcome associated with the use of hernia mesh.The degree to which the device used to treat the patient may have caused or contributed to a post-op complication is unknown.No lot number has been provided; a review of the manufacturing records is not possible.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the event date.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 a post-op complication.Per medical records review, about 1 month's post implant of ventralight st mesh, patient was diagnosed with hernia recurrence.During a subsequent procedure adhesions were noted and adhesiolysis was performed.Hernia recurrence and adhesions are known inherent risks of surgery/use of the device and are listed in the instructions-for-use supplied with the device as possible complications.This supplemental mdr represents the ventralight st mesh (device #1).An additional emdr's were submitted to represent capsure (device #2 & #3).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
Attorney alleges multiple patients he represents have experience unspecified injury and allege they may have required additional medical/surgical treatment.Attorney alleges this patient was treated with a ventralight st.Case-specific details not provided.Addendum per information provided by patient's attorney: (b)(6) 2020 - patient was diagnosed with symptomatic parastomal hernia thereby underwent laparoscopic sugarbaker repair with the implant of ventralight st mesh.Per operative notes, ¿omental adhesions to previous midline laparotomy wound and right iliac fossa taken down and parastomal hernia defect closed with sutures.A ventralight st mesh (device #1) was placed using endocatch device.Mesh tacked to abdominal wall with 2 rows of tackers (device #2, #3) and checked to ensure colon held loosely.Holding sutures tied to fascia and cut." (b)(6) 2020 to (b)(6) 2022 - patient was diagnosed with hernia recurrence, abdominal pain thereby had painkiller medications.Surgeon felt that the pain was caused by clips (tackers - device #2, #3) that were used to secure the mesh and likely there may be an irritated perforating nerve in abdominal wall.(b)(6) 2022 - patient had diagnostic laparoscopy and removal of clips (tackers - device #2, #3) from abdomen.(b)(6) 2022 - patient underwent laparoscopy, adhesiolysis and removal of clips (tackers) from anterior abdominal wall.Per operative notes, ¿dense adhesions of small bowel to mesh were noted.Tedious adhesiolysis performed to free small bowel loops from mesh limiting to exposing only the lateral and inferior aspects around the colostomy where the pain localized.Serosal tear to small bowel sustained and sutured.Total of (b)(4) protacs (tackers - device #2, #3) removed.¿.

• 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: 19214762
• Report Number: 1213643-2024-00215
• Device Sequence Number: 15480028
• Product Code: FTL
• UDI-Device Identifier: 00801741031595
• UDI-Public: (01)00801741031595(17)201228(10)HUCZ1108
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/28/2020
• Device Catalogue Number: 5954113
• Device Lot Number: HUCZ1108
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 08/27/2024
• 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; Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 82 KG