MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 SORBAFIX ENHANCED; STAPLE, IMPLANTABLE

Catalog Number	0113116
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	11/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2019 - patient was diagnosed with umbilical hernia and supraumbilical hernia thereby underwent laparoscopic repair with implant of ventralight st with echo ps (device 1).Per operation notes, "a palmar¿s point incision in the left upper quadrant skin was incised.A supraumbilical and umbilical hernia was identified.Anterior abdominal wall adhesions were taken down and decompressed the chronically incarcerated umbilical hernia.Hernia contents were old omental fat and appeared to be an additional supra umbilical defect.Second supraumbilical defect was noted.A ventralight st with echo ps (device 1) was placed into the abdomen and secured with sutures and sorbafix enhanced (device 2)." on (b)(6) 2020 - patient was diagnosed with incisional hernia, fascia erosion thereby underwent open repair with excision of sorbafix enhanced (device 2) and implant of ventralex st mesh (device 3).Per operation notes, "an incision was made above the supraumbilical region.An eroded sorbafix enhanced (device 2) was noted in the subcutaneous tissues of upper left incision and it was removed.Prominent tack was again noted at the mid-left incision and it was removed.Mesh (device 1) laxity/peripheral mesh failure was noted.A ventralex st mesh (device 3) was placed and secured to the anterior abdominal wall.".
Additional Manufacturer Narrative
Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.This mdr represents the sorbafix enhanced (device 2).An additional supplemental emdr was submitted to represent the ventralight st with echo ps (device 1).Note, the manufacturing date (15-jul-2019) is considered to be a best estimate.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.

• Brand Name: SORBAFIX ENHANCED
• Common Device Name: STAPLE, IMPLANTABLE
• 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: 24801207
• Report Number: 1213643-2026-00446
• Device Sequence Number: 10679200
• Product Code: GDW
• UDI-Device Identifier: 00801741016707
• UDI-Public: (01)00801741016707(17)210628(10)HUDU1076
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K111153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2026

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: 06/28/2021
• Device Catalogue Number: 0113116
• Device Lot Number: HUDU1076
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2019
• 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: 37 YR
• Patient Sex: Female