MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PHASIX ST MESH; SURGICAL MESH

Catalog Number	1202530
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has been returned for evaluation.However, the sample evaluation is currently ongoing.When the sample evaluation has been completed a supplemental emdr will be submitted.Review of manufacturing records shows the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in january 2023.Note: section a through f - the information provided by bd 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 bd.
Event or Problem Description
As reported, upon opening of the phasix st mesh package, a foreign material was found inside the sterile pouch.It was reported that the procedure was completed using another mesh.There was no reported patient injury.
Event or Problem Description
As reported, upon opening of the phasix st mesh package, a foreign material was found inside the sterile pouch.It was reported that the procedure was completed using another mesh.There was no reported patient injury.
Additional Manufacturer Narrative
The subject device has been returned for evaluation.However, the sample evaluation is currently ongoing.When the sample evaluation has been completed a supplemental emdr will be submitted.Review of manufacturing records shows the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 56 units released for distribution in (b)(6) 2023.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the sample evaluation results.Evaluation of the sample finds a foreign matter (hair) on the device.A clear ¿film¿ had been placed over the product by the end user to keep the foreign matter affixed to the product.The foreign matter is not fully attached or embedded into the unit.As the foreign matter was identified after opening the package at the user facility, it cannot be determined when the foreign matter presented.Based on visual and manufacturing process evaluation performed, root cause could not be determined.Updated fields: b4, g3, g6, h2, h3, h6, h10 note: section a through f - the information provided by bd 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 bd.H3 other text : sample evaluated.

• Brand Name: PHASIX ST MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 17032870
• Report Number: 1213643-2023-00215
• Device Sequence Number: 7012019
• Product Code: OWT
• UDI-Device Identifier: 00801741095375
• UDI-Public: (01)00801741095375
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023

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: 09/28/2024
• Device Catalogue Number: 1202530
• Device Lot Number: HUGX1935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/10/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown