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

Catalog Number	0115610
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Cellulitis (1768); Renal Failure (2041); Reaction (2414)
Date of Event	08/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no connection that can be made at this time between the reported post-operative complications and any problem with the bard/davol device used to treat the patient.As reported, initially acute renal failure by cellulitis was suspected.The doctors now suspect that the patient may have had an allergic type reaction to the mesh, which resolved once the mesh was explanted.However, at this time no difinitive conclustions can be made.Without a lot number a review of the manufacturing records is not possible.Should additional information be obtained, 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.Not rerturned.
Event or Problem Description
The following was reported to davol: on (b)(6) 2017 - the patient was implanted with a bard modified onflex mesh.On (b)(6) 2017 - the patient presented with abdominal wall cellulitis and renal failure and was treated with infusion and medication.On (b)(6) 2017 - the patient underwent explant of the mesh.The renal failure and abdominal wall findings (cellulitis) were resolved following explant of the mesh and the patient was discharged from the hospital.As reported initially, acute renal failure by cellulitis was suspected due to clinical findings.At that time the infusion was started and after a blood test and explant of the mesh, an allergic reaction to the mesh was suspected.

• Brand Name: MODIFIED ONFLEX
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7127621
• Report Number: 1213643-2017-01046
• Device Sequence Number: 1798577
• Product Code: FTL
• UDI-Device Identifier: 00801741095399
• UDI-Public: (01)00801741095399
• Combination Product (Y/N): N
• PMA/510(K) Number: K142706
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2017

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 Catalogue Number: 0115610
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 12/18/2017
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 61 YR