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

Catalog Number	0112670
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Pain (1994)
Date of Event	03/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided by the complainant and review of medical records, the patient experienced pain post implant of the flat mesh.Per medical records five years post implant the patient underwent explant of the flat mesh.The medical records indicate that following explant the pain was gone and the incision was healed with no further complaints.The explanting surgeon noted that "the mesh was certainly too close to the surface and had not healed properly." based on the information provided, no definitive conclusion can be made, however it would appear that the placement of the implant contributed to the patient's postoperative course.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in january, 2013.Should additional information be provided, a supplemental emdr will be submitted.Not returned - sample unavailable.
Event or Problem Description
The following was reported via maude event report (mw5095893): "inguinal hernia/bulge in the abdominal wall/first noticed after doing sit-ups about 4 months earlier had bard surgical repair with mesh.Started having pain and on (b)(6) 2020 due to shooting and radiating pain in abdomen he had it removed at (b)(6) once removed doing great no issues." the following is based on medical records provided by the contact: (b)(6) 2015: the patient underwent an open umbilical hernia repair with implant of a bard/davol 2x12" flat mesh.(b)(6) 2019 and (b)(6) 2019: about 4 years later, the patient had multiple complaints of sharp abd pain and discomfort.(b)(6) 2019: the patient had a surgeon consultation who examined the patient; as reported during the exam the patient felt "ripping and tearing," and the surgeon stated he did not feel a hernia.As reported the pain worsened for the patient after the exam.(b)(6) 2019: an abdominal ct indicated a normal ct scan with no evidence of hernia recurrence.(b)(6) 2020: the patient underwent an additional surgical procedure with explant of the bard/davol flat mesh.(b)(6) 2020: the patient had a follow up phone call (telemedicine) due to covid-19 with surgeon and reported that the patient was doing great, no issues.The previously reported nerve pain was gone, the incision was healed and had no further complaints.Upon further communication, it was reported that the patient had no recurrent hernia noted and had no physical revisit due to covid-19; the surgeons reported that the mesh was certainly too close to the surface and had not healed properly.
Event or Problem Description
The following was reported via maude event report (mw5095893): "inguinal hernia/bulge in the abdominal wall/first noticed after doing sit-ups about 4 months earlier had bard surgical repair with mesh.Started having pain and on (b)(6) 2020 due to shooting and radiating pain in abdomen he had it removed at (b)(6) once removed doing great no issues." the following is based on medical records provided by the contact: (b)(6) 2015: the patient underwent an open umbilical hernia repair with implant of a bard/davol 2x12" flat mesh.(b)(6) 2019: about 4 years later, the patient had multiple complaints of sharp abd pain and discomfort.(b)(6) 2019: the patient had a surgeon consultation who examined the patient; as reported during the exam the patient felt "ripping and tearing," and the surgeon stated he did not feel a hernia.As reported the pain worsened for the patient after the exam.(b)(6) 2019: an abdominal ct indicated a normal ct scan with no evidence of hernia recurrence.(b)(6) 2020: the patient underwent an additional surgical procedure with explant of the bard/davol flat mesh.(b)(6) 2020: the patient had a follow up phone call (telemedicine) due to covid-19 with surgeon and reported that the patient was doing great, no issues.The previously reported nerve pain was gone, the incision was healed and had no further complaints.Upon further communication, it was reported that the patient had no recurrent hernia noted and had no physical revisit due to covid-19; the surgeons reported that the mesh was certainly too close to the surface and had not healed properly.
Additional Manufacturer Narrative
Based on the information provided by the complainant and review of medical records, the patient experienced pain post implant of the flat mesh.Per medical records five years post implant the patient underwent explant of the flat mesh.The medical records indicate that following explant the pain was gone and the incision was healed with no further complaints.The explanting surgeon noted that "the mesh was certainly too close to the surface and had not healed properly." based on the information provided, no definitive conclusion can be made, however it would appear that the placement of the implant contributed to the patient's postoperative course.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in january, 2013.Addendum: h11: this is an addendum to the initial emdr.This supplemental emdr is submitted to report the corrected date of event.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 : not returned - sample unavailable.

• Brand Name: BARD FLAT MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10540681
• Report Number: 1213643-2020-08410
• Device Sequence Number: 3209069
• Product Code: FTL
• UDI-Device Identifier: 00801741016523
• UDI-Public: (01)00801741016523
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2020

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: 01/28/2018
• Device Catalogue Number: 0112670
• Device Lot Number: HUWL1294
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Weight: 84