PERFIX PLUG
Report
- Report Number
- 1213643-2018-00322
- Event Type
- Injury
- Date Received
- February 20, 2018
- Date of Event
- September 23, 2013
- Report Date
- October 4, 2024
- Manufacturer
- DAVOL INC., SUB. C.R. BARD, INC.
- Product Code
- FTL
- UDI-DI
- 00801741016653
- PMA / PMN Number
- K922916
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- 003
Narratives
BASED ON THE INFORMATION PROVIDED WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY THE BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED BY THE PATIENT¿S ATTORNEY. THE INFORMATION PROVIDED ALLEGES THAT THE PATIENT UNDERWENT ADDITIONAL SURGERY "TO REMOVE MESH AND RECURRENT REPAIR" HOWEVER THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND MEDICAL RECORDS ARE NOT AVAILABLE AT THIS TIME. RECURRENCE IS A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE AS A POSSIBLE COMPLICATION. ADDENDUM: H11: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED AND TO CORRECT THE MANUFACTURING DATE. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THERE IS NO CHANGE TO INITIAL DETERMINATION, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORDS REVIEW, ABOUT 3 YEARS AND 8 MONTHS POST IMPLANT OF PERFIX PLUG, PATIENT WAS DIAGNOSED WITH MESH SHRINKAGE, MESH MIGRATION, FIBROSIS AND PAIN THEREBY UNDERWENT REMOVAL OF MESH. PER OP NOTES, "THE PREVIOUS MESH WAS SHRUNK IN SIZE AND MIGRATED". A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. 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.
ADDENDUM TO THE PREVIOUS INFORMATION. THIS SUPPLEMENTAL EMDR IS BEING SENT TO PROVIDE THE CORRECT MANUFACTURE AND EXPIRATION DATE FOR THE PERFIX PLUG DEVICE. CORRECTED FIELDS:DEVICE MANUFACTURE DATE. UPDATED FIELDS: MFR SITE, PMA/510K, IF FOLLOW-UP, WHAT TYPE.
THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2010: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INGUINAL HERNIA. A BARD/DAVOL PERFIX PLUG, REFERENCE NUMBER 0112950, LOT NUMBER HURD0814 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2013: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE MESH AND RECURRENT HERNIA. AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE PERFIX PLUG. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE #1). PER OPERATIVE NOTES, ¿A SMALL DEFECT ON THE FLOOR OF THE INGUINAL CANAL WAS NOTED AND ALSO FOUND ANOTHER INDIRECT INGUINAL HERNIA. A SMALL PLUG WAS PLACED IN THE INTERNAL INGUINAL RING AND A SMALL PATCH WAS ALSO PLACED TO REINFORCE THE FLOOR OF THE INGUINAL FLOOR.¿ (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH PAIN THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESH AND IMPLANT OF 3DMAX MESH (DEVICE #2). PER OP NOTES, ¿THE PREVIOUSLY PLACED SUTURES WERE IDENTIFIED. THE PREVIOUS MESH WAS SHRUNK IN SIZE AND THE MESH WAS DISSECTED FREE FROM THE SURROUNDING TISSUES. THE MESH PLUG WAS MIGRATED, AND THIS WAS EXCISED. THERE IS NO EVIDENCE OF HERNIA RECURRENCE. A MEDIUM SIZED 3DMAX MESH WAS TRIMMED AND USED OVER THE COOPER LIGAMENT.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD BOWEL PERFORATION, MESH MIGRATION, MESH SHRINKAGE, HERNIA RECURRENCE, EXCISION OF MESH, PAIN AND EMOTIONAL INJURIES.
THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6)2010: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INGUINAL HERNIA. A BARD/DAVOL PERFIX PLUG, REFERENCE NUMBER 0112950, LOT NUMBER HURD0814 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6)2013: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE MESH AND RECURRENT HERNIA. AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE PERFIX PLUG.
BASED ON THE INFORMATION PROVIDED WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY THE BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED BY THE PATIENT¿S ATTORNEY. THE INFORMATION PROVIDED ALLEGES THAT THE PATIENT UNDERWENT ADDITIONAL SURGERY "TO REMOVE MESH AND RECURRENT REPAIR" HOWEVER THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND MEDICAL RECORDS ARE NOT AVAILABLE AT THIS TIME. RECURRENCE IS A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE AS A POSSIBLE COMPLICATION. SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR WILL BE SUBMITTED. NOTE: THE INFORMATION PROVIDED BY BARD 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 BARD. NOT RETURNED.
THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2010: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INGUINAL HERNIA. A BARD/DAVOL PERFIX PLUG, REFERENCE NUMBER 0112950, LOT NUMBER HURD0814 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2013: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE MESH AND RECURRENT HERNIA. AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE PERFIX PLUG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 127261 | PERFIX PLUG | SURGICAL MESH | FTL | DAVOL INC., SUB. C.R. BARD, INC. | NA | HURD0814 | 00801741016653 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Female | Disability| R |