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

Catalog Number	0010103
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abdominal Pain (1685); Pain (1994)
Date of Event	02/10/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no contact information included on the maude event report; therefore requests for additional information cannot be made at this time.A lot number was not provided therefore a review of the manufacturing records cannot be conducted.Based on the information provided we are unable to determine to what extent, if any, the bard device may have caused or contributed to the patient¿s reported post implant pain.Should the patient contact davol and additional information is provided, a supplemental mdr will be provided.Remains implanted.
Event or Problem Description
The following was reported via maude event report (mw5070931): "had pain in abdomen went in for laparoscopic surgery and dr.Found a spigelian hernia used a 3 inch round composix mesh (kugel patch) with stay sutures fixed to the abdominal wall using a puncture closure device and tacking staples.Ever since the surgery i have had abdominal pain but it is a different kind of pain.I have seen another surgeon about it.He said mesh cannot be removed but could do laparoscopic surgery again.He can possibly reposition the tacks.I have been miserable since surgery.

• Brand Name: KUGEL PATCH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 6798898
• Report Number: 1213643-2017-00509
• Device Sequence Number: 1267974
• Product Code: FTL
• UDI-Device Identifier: 00801741016356
• UDI-Public: (01)00801741016356
• Combination Product (Y/N): N
• PMA/510(K) Number: K963141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/16/2017

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: 0010103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 08/16/2017
• 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