3DMAX
Report
- Report Number
- 1213643-2024-091568
- Event Type
- Injury
- Date Received
- March 27, 2024
- Report Date
- April 22, 2024
- Manufacturer
- DAVOL INC., SUB. C.R. BARD, INC.
- Product Code
- FTL
- PMA / PMN Number
- K081010
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 003
Narratives
NO CONCLUSIONS CAN BE MADE. THE PATIENT'S ATTORNEY ALLEGES ADVERSE PATIENT OUTCOME ASSOCIATED WITH THE HERNIA MESH USED TO TREAT THE PATIENT. THE PATIENT'S ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION; HOWEVER, NO DETAILS HAVE BEEN PROVIDED. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. ADDENDUM: H11: THIS IS AN ADDENDUM TO THE INITIAL EMDR SUBMITTED (MDR NUMBER 1213643-2024-091568). THIS SUPPLEMENTAL EMDR IS BEING SUBMITTED TO CORRECT THE COMPLAINANT E-MAIL ADDRESS WHICH WAS INADVERTENTLY UPDATED. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
NO CONCLUSIONS CAN BE MADE. THE PATIENT'S ATTORNEY ALLEGES ADVERSE PATIENT OUTCOME ASSOCIATED WITH THE HERNIA MESH USED TO TREAT THE PATIENT. THE PATIENT'S ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION; HOWEVER, NO DETAILS HAVE BEEN PROVIDED. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. NOT RETURNED.
ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL 3DMAX MESH ON (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 3DMAX MESH. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.
ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL 3DMAX MESH ON (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 3DMAX MESH. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2060840 | 3DMAX | SURGICAL MESH | FTL | DAVOL INC., SUB. C.R. BARD, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention |