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

Catalog Number	1190500
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, a tear was noted in the inner mesh pouch of the phasix mesh.Evaluation of the returned sample finds that the pouch was sealed correctly and the pouch integrity was intact.The pouch was received opened from the bottom manufacturing seal with a tear visible in the pouch on the back non-label side.Note, the package is intended to be opened from the chevron end (top) and not the bottom seal.The tear starts in the manufacturing seal, moves diagonal into the vendor seal and into the foil.The tear began as the user opened across the manufacturing seal.The user also opened the pouch from the chevron end with no anomalies.Based on sample examination it appears while opening the pouch from the bottom seal the user encountered an area of increased seal resistance in the manufacturing seal where the tear began.This caused material fracture when opening the pouch.Examination of the seal confirms there was no breach to the package prior to opening.Based on the sample evaluation and investigation performed, the issue presented due to the user opening the pouch from the bottom seal and not the intended chevron end.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in may 2021.
Event or Problem Description
As reported, on (b)(6) 2021, a tear was noted in the inner mesh pouch while opening the fully sealed outer package of a bard/davol phasix mesh.It was reported that the mesh was not used and another phasix mesh was used to complete the procedure.It was further reported that the outer product box had intact seals prior to opening.There was no reported patient injury.

• Brand Name: PHASIX MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 12358510
• Report Number: 1213643-2021-20263
• Device Sequence Number: 19788854
• Product Code: OOD
• UDI-Device Identifier: 00801741077708
• UDI-Public: (01)00801741077708
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2021

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: 01/28/2023
• Device Catalogue Number: 1190500
• Device Lot Number: HUFP1976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 08/24/2021
• 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: Other