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

Catalog Number	1191530
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hematoma (1884); Obstruction/Occlusion (2422)
Date of Event	11/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported per prevent clinical trial (b)(4): on (b)(6) 2021, during an open relaparotomy ostomy procedure, the study patient was implanted with a bard/davol phasix mesh which was trimmed and placed in an onlay fashion.Skin incisions ( size-18cm) were made straight near the epigastric and umbilical region.Midline fascia closure was achieved using a non-bard/davol single suture, in a running stitch technique.Also, an absorbable 1-pds suture was used for securing the mesh and final skin closure was achieved with staples.As reported, there was no active skin pathology at the time of implant and antibiotics were administered peri-operatively; the patient was discharged from the hospital on (b)(6) 2021.As reported, on (b)(6) 2021, the study patient was diagnosed with a hematoma that required staple removal.The subject patient was admitted to the hospital and was administered vancomycin (750mg) every 12 hrs.On admission and switched to po augmentin on admit day.As reported, the hematoma was evacuated bedside in the emergency department.Culture was not taken.The staples were removed at the lower incision and the study patient was discharged home with three times weekly dressing changes with aquacel ag packing with home health.As reported, the patient is tolerating the packing changes and reports some drainage from the area, but is controlled with dressing.The study clinician has assessed the reported adverse event (ae) as possibly related to the study device and definitely related to the index procedure.The adverse event has been assessed to be of mild severity.
Additional Manufacturer Narrative
As reported, 11 days post-implant of the phasix mesh, the patient experienced a postoperative hematoma that required evacuation and staple removal.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and definitely related to the index procedure; however, based on the information provided, no conclusion can be made.Hematoma is a known inherent risk of surgery and is listed in the adverse reactions section of the instructions-for-use (ifu) supplied with the device as a possible complication.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.Should additional information be provided, a supplemental mdr will be submitted.
Additional Manufacturer Narrative
As reported, 11 days post-implant of the phasix mesh, the patient experienced a postoperative hematoma that required evacuation and staple removal.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and definitely related to the index procedure; however, based on the information provided, no conclusion can be made.Hematoma is a known inherent risk of surgery and is listed in the adverse reactions section of the instructions-for-use (ifu) supplied with the device as a possible complication.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.Addendum: this is an addendum to the previously submitted mdr to report additional information provided.As reported, seven months post-implant, the patient with a medical history of small bowel obstruction (sbo), developed a sbo and underwent exploratory surgery, during which the mesh was explanted.The clinician has assessed the adverse event to be not related the study device and possibly related to the index procedure, however, based on the information provided, no conclusion can be made.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 : not returned - mesh explanted.
Event or Problem Description
As reported per prevent clinical trial (b)(6): on (b)(6) 2021, during an open relaparotomy ostomy procedure, the study patient was implanted with a bard/davol phasix mesh which was trimmed and placed in an onlay fashion.Skin incisions ( size-18cm) were made straight near the epigastric and umbilical region.Midline fascia closure was achieved using a non-bard/davol single suture, in a running stitch technique.Also, an absorbable 1-pds suture was used for securing the mesh and final skin closure was achieved with staples.As reported, there was no active skin pathology at the time of implant and antibiotics were administered peri-operatively; the patient was discharged from the hospital on (b)(6) 2021.As reported, on (b)(6) 2021, the study patient was diagnosed with a hematoma that required staple removal.The subject patient was admitted to the hospital and was administered vancomycin (750mg) every 12 hrs.On admission and switched to po augmentin on admit day.As reported, the hematoma was evacuated bedside in the emergency department.Culture was not taken.The staples were removed at the lower incision and the study patient was discharged home with three times weekly dressing changes with aquacel ag packing with home health.As reported, the patient is tolerating the packing changes and reports some drainage from the area, but is controlled with dressing.The study clinician has assessed the reported adverse event (ae) as possibly related to the study device and definitely related to the index procedure.The adverse event has been assessed to be of mild severity.Addendum per email notification from clinical trial site: on (b)(6) 2022, the patient was diagnosed with small bowel obstruction (sbo) and underwent an exploratory laparotomy with complete removal of the phasix mesh.As reported, this adverse event has been assessed per the study clinician as moderate in severity and not recovered/not resolved.The study clinician has assessed the adverse event to be not related the study device and possibly related to the index procedure.The reported event has been assessed to meet the definition of a serious adverse event (sae).The reported event does not meet the definition of an unidentified adverse device event (uade).

• Brand Name: PHASIX 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: 13006110
• Report Number: 1213643-2021-20462
• Device Sequence Number: 4926035
• Product Code: OOD
• UDI-Device Identifier: 00801741107610
• UDI-Public: (01)00801741107610
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K161424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022

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: 12/28/2021
• Device Catalogue Number: 1191530
• Device Lot Number: HUDY1470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2020
• 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; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 74 KG