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

Catalog Number	0117070
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported the sample is not available for return.It was reported that the issue presented after opening the package.Without having the sample there is no way of knowing what type of foreign material is being alleged and whether it was present prior to opening or if it may have been introduced to the product/package after being opened by the user.The information provided is limited and did not include contact information, therefore we are unable to request addition details.With the information provided, no conclusion can be made.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this production lot of 525 units released for distribution in january, 2018.Not returned.
Event or Problem Description
The following was reported to davol by the (b)(6) center: it was reported that on (b)(6) 2019 a foreign material was found after opening the perfix light plug package.As reported the problem was noted out of the package and the device was not used to treat the patient.There was no patient injury reported.As reported the sample is not available for return.

• Brand Name: PERFIX LIGHT PLUG
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8666929
• Report Number: 1213643-2019-04617
• Device Sequence Number: 2292897
• Product Code: FTL
• UDI-Device Identifier: 00801741030963
• UDI-Public: (01)00801741030963
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2022
• Device Catalogue Number: 0117070
• Device Lot Number: HUBX1664
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1