MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. 3DMAX; SURGICAL MESH

Catalog Number	0115322
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146); Tingling (2171)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
With the limited information provided, at this time no conclusion can be made as to the degree to which the mesh implant may have caused or contributed to the intermittent burning, pulling and mild pain sensations the patient alleges to have been experiencing.Additional information has been requested.Should additional information be provided, a supplemental mdr will be submitted.This mdr is associated to the bard 3dmax mesh alleged to have been implanted on the right side, an additional mdr was submitted associated to the bard 3dmax mesh alleged to have been implanted on the left side.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 is reported that on (b)(6) 2011 the patient underwent the repair of bilateral inguinal hernias and was implanted with two bard 3dmax mesh devices.As reported for the last year and a half the patient has been experiencing intermittent burning, pulling, tingling and mild pain / pinching sensations on one or both sides.It is reported that these symptom have continued to increase in intensity and duration.
Additional Manufacturer Narrative
This is an addendum to the initial mdr to document a correction to the expiration date of the device.Corrected field:(expiration date, udi).

• Brand Name: 3DMAX
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 6974377
• Report Number: 1213643-2017-00721
• Device Sequence Number: 16443340
• Product Code: FTL
• UDI-Device Identifier: 00801741030772
• UDI-Public: (01)00801741030772(17)140430(10)HUVB2196
• Combination Product (Y/N): N
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2017

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 Expiration Date: 04/30/2016
• Device Catalogue Number: 0115322
• Device Lot Number: HUVB2196
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2017
• Supplement Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 11/22/2017
• 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: Required Intervention