MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX MID; SURGICAL MESH

Catalog Number 0116321

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2021

Event Type  malfunction  

Manufacturer Narrative

Note, the date of event and date of implant are provided as a best estimate based on the information reported of event occurring between (b)(6) 2021.The customer was not able to confirm the lot number for the large right 3d max mid used to treat the patient.We have narrowed possible product lots supplied as follows: 0116321/hufpab03 (ordered qty 4 april 7) or 0116321/hufpab16 (ordered qty.2 april 27).0116321/hufpab03 as the most probable device.Review of manufacturing records for lots hufpab03, hufpab16, hufnab20 confirm products were manufactured to specification, with no indication of a manufacturing related cause for the event reported.No labeling discrepancy were found, retain labels conformed to specification.A definitive conclusion cannot be made at this time to confirm the reported condition.Hospital did not provide the patient charts to confirm the condition, and as such a clerical error cannot be ruled out.There have been no similar complaints reported for any of the identified lots.Not returned remains implanted.

Event Description

As reported, a large right 3dmax mid mesh (cat# 0116321) was used in a right inguinal hernia repair procedure.The implant type (right) and size (large) were confirmed per the product carton label by the or tech and circulator (nurse).The surgeon placed the right side mesh without any complication.It was reported that at the close of the procedure, the circulator peeled the patient trace label from the inner sterile package and placed in the patient chart.As reported the patient chart was being reviewed by the hospital revenue department for billing.The auditor noted that the product sticker cat# was 0116311 on the chart was for a large left 3dmax mid mesh, and not a right side mesh as listed in the operative report.This was reported to the or staff who re confirmed they both checked the outer box label when pulling the mesh for the case and it was labeled for a large right 3dmax mid mesh.The surgeon also confirmed that the proper size/type device was used and was placed correctly on the right side of the patient.Hospital reported the event to the manufacturer.

• Brand Name: 3DMAX MID
• Type of Device: 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: 11902228
• MDR Text Key: 256059807
• Report Number: 1213643-2021-20132
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741200786
• UDI-Public: (01)00801741200786
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/14/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2023
• Device Catalogue Number: 0116321
• Device Lot Number: HUFPAB03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 05/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2021
• 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
• Patient Outcome(s): Other