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

Catalog Number 0117070

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2019

Event Type  malfunction  

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 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
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: laura sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 8666929
• MDR Text Key: 146937219
• Report Number: 1213643-2019-04617
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030963
• UDI-Public: (01)00801741030963
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K092032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2022
• Device Catalogue Number: 0117070
• Device Lot Number: HUBX1664
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1