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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX MID SURGICAL MESH Back to Search Results
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.
 
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Brand Name3DMAX MID
Type of DeviceSURGICAL 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 Key11902228
MDR Text Key256059807
Report Number1213643-2021-20132
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200818
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial
Report Date 05/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0116321
Device Lot NumberHUFPAB03
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/26/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/28/2021 Patient Sequence Number: 1
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