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

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.

• Brand Name: 3DMAX
• 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: 12331311
• MDR Text Key: 266883243
• Report Number: 1213643-2021-20255
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K081010
• Number of Events Reported: 1
• 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 Received: 08/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNKAA001
• 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 Received: 07/26/2021
• 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