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

Catalog Number	5950040
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Rash (2033)
Date of Event	07/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient experienced a rash post-implant of the bard/davol ventrio st mesh.The patient's allergist has been provided with a sample mesh to perform reactivity testing.As reported, the testing has not been scheduled.Based on the information provided to date, no conclusion can be made.Allergic reaction is a known inherent risk of hernia repair surgery and is listed in the adverse reactions section of the instructions for use, supplied with the device as a possible complication.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 147 units released for distribution in feb, 2021.If/when the testing is performed and the results provided, a supplemental mdr will be submitted.Not returned ¿ remains implanted.
Event or Problem Description
As reported, a bard/davol ventrio st mesh was implanted during july 2021 and the patient has since developed a rash.As reported, the patient is being treated by the patient's allergist; specific treatment is unknown.As reported, the surgeon and allergist would like to perform a reactivity test, however the test has yet to be performed.
Event or Problem Description
As reported, a bard/davol ventrio st mesh was implanted during (b)(6) 2021 and the patient has since developed a rash.As reported, the patient is being treated by the patient's allergist; specific treatment is unknown.As reported, the surgeon and allergist would like to perform a reactivity test, however the test has yet to be performed.Addendum: as reported, the patient underwent reactivity testing in (b)(6) 2022.The results were negative for any reaction to the ventrio st mesh.As reported, the patient has been seen at cleveland clinic for surgical consultation to have the mesh removed per the patient¿s request, as she feels her symptoms are related to the mesh.
Additional Manufacturer Narrative
As reported, the patient experienced a rash post-implant of the bard/davol ventrio st mesh.The patient's allergist has been provided with a sample mesh to perform reactivity testing.As reported, the testing has not been scheduled.Based on the information provided to date, no conclusion can be made.Allergic reaction is a known inherent risk of hernia repair surgery and is listed in the adverse reactions section of the instructions for use, supplied with the device as a possible complication.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 147 units released for distribution in feb, 2021.Addendum: this is an addendum to the previously submitted mdr to document reactivity test results.Reactivity testing has been performed and as reported the results were negative for an allergic response to the mesh sample.It is unknown at this time, what is causing the patient's reaction.However, based on testing performed the postoperative condition; rash does not appear to be caused by the bard/davol mesh used to treat the patient.Updated fields: b4, b5 (event description).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.
Additional Manufacturer Narrative
As reported, the patient experienced a rash post-implant of the bard/davol ventrio st mesh.The patient's allergist has been provided with a sample mesh to perform reactivity testing.As reported, the testing has not been scheduled.Based on the information provided to date, no conclusion can be made.Allergic reaction is a known inherent risk of hernia repair surgery and is listed in the adverse reactions section of the instructions for use, supplied with the device as a possible complication.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 147 units released for distribution in (b)(6) 2021.Addendum: this is an addendum to the previously submitted mdr to document reactivity test results.Reactivity testing has been performed and as reported the results were negative for an allergic response to the mesh sample.It is unknown at this time, what is causing the patient's reaction.However, based on testing performed the postoperative condition; rash does not appear to be caused by the bard/davol mesh used to treat the patient.Updated fields: b4, b5 (event description), b6 (relevant tests and lab data), h10 addendum: this is an addendum to the previously submitted semdr to correct the annex f code and age unit.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.
Event or Problem Description
As reported, a bard/davol ventrio st mesh was implanted during (b)(6) 2021 and the patient has since developed a rash.As reported, the patient is being treated by the patient's allergist; specific treatment is unknown.As reported, the surgeon and allergist would like to perform a reactivity test, however the test has yet to be performed.Addendum: as reported, the patient underwent reactivity testing in (b)(6) 2022.The results were negative for any reaction to the ventrio st mesh.As reported, the patient has been seen at cleveland clinic for surgical consultation to have the mesh removed per the patient¿s request, as she feels her symptoms are related to the mesh.

• Brand Name: VENTRIO ST
• 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: 14461993
• Report Number: 1213643-2022-00259
• Device Sequence Number: 4482697
• Product Code: FTL
• UDI-Device Identifier: 00801741031533
• UDI-Public: (01)00801741031533
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2022

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: 10/28/2022
• Device Catalogue Number: 5950040
• Device Lot Number: HUEY1409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2022
• Supplement Date Received by Manufacturer: 11/02/2022; 11/10/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 11/10/2022; 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2021
• 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: 65 YR
• Patient Sex: Unknown