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

Catalog Number	1201020
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	02/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cause of the patient's postoperative complications cannot be determined.As reported the small bowel obstruction resolved with minimal intervention.There is no identification that the phasix st mesh caused the reported problem.If additional information is provided, a supplemental emdr will be submitted.The information provided by bard 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 bard.Remains implanted.
Event or Problem Description
It was reported that a patient who is part of a clinical study was treated for postoperative partial small bowel obstruction.On (b)(6) 2017 - the patient underwent a robotic assisted intra-abdominal (right, lateral stoma site) hernia repair and was implanted with a davol phasix st mesh.The mesh was fixated with absorbable monofilament suture at 3 fixation points.The mesh was not trimmed and it extended beyond the margins of the defect by at least 5cm.On (b)(6) 2018 - the patient was hospitalized with a partial small bowel obstruction and was given ivf, comfort measures.Upon admission the patient's lactic acid reading was 4.8 the reading dropped to 0.6, the small bowel obstruction resolved and the patient was discharged on (b)(6) 2018.The clinician assessed the ae as mild in severity, possibly device related and possibly procedure related.

• Brand Name: PHASIX ST 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: 7525152
• Report Number: 1213643-2018-01586
• Device Sequence Number: 19188738
• Product Code: OWT
• UDI-Device Identifier: 00801741095313
• UDI-Public: (01)00801741095313
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other,stu
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/18/2018

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: 09/28/2018
• Device Catalogue Number: 1201020
• Device Lot Number: HUAV2562
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 05/18/2018
• 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: 62 YR