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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 SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX SURGICAL MESH Back to Search Results
Catalog Number UNKAA001
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Swelling/ Edema (4577)
Event Date 06/21/2021
Event Type  Injury  
Manufacturer Narrative
As reported, post-implant of the 3dmax mesh, the patient experienced swelling and pain. No additional information is available at this time. Based on the information provided, no conclusion can be made. No lot number has been provided; therefore, a review of the manufacturing records is not possible. Note, the date of event is consider to be a best estimate as (b)(6) 2021 based on date of implant. Should additional information be provided a supplemental mdr will be submitted. Not returned - remains implanted.
 
Event Description
As reported, the patient underwent right inguinal hernia repair on (b)(6) 2021, during which a bard/davol 3dmax mesh was implanted. It was reported that the patient¿s right inguinal area was swollen and uncomfortable in the area of the repair. After symptomatic pain relief, the patient's condition improved.
 
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Brand Name3DMAX
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 Key12331311
MDR Text Key266883243
Report Number1213643-2021-20255
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K081010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial
Report Date 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKAA001
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 Received07/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/17/2021 Patient Sequence Number: 1
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