PHASIX MESH
Report
- Report Number
- 1213643-2021-20462
- Event Type
- Injury
- Date Received
- December 14, 2021
- Date of Event
- November 30, 2021
- Report Date
- April 6, 2022
- Manufacturer
- DAVOL INC., SUB. C.R. BARD, INC. -1213643
- Product Code
- OOD
- UDI-DI
- 00801741107610
- PMA / PMN Number
- K161424
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
AS REPORTED, 11 DAYS POST-IMPLANT OF THE PHASIX MESH, THE PATIENT EXPERIENCED A POSTOPERATIVE HEMATOMA THAT REQUIRED EVACUATION AND STAPLE REMOVAL. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE COURSE AS BEING ¿POSSIBLY¿ RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE; HOWEVER, BASED ON THE INFORMATION PROVIDED, NO CONCLUSION CAN BE MADE. HEMATOMA IS A KNOWN INHERENT RISK OF SURGERY AND IS LISTED IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE (IFU) SUPPLIED WITH THE DEVICE AS A POSSIBLE COMPLICATION. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION, WITH NO INDICATION OF A MANUFACTURING RELATED CAUSE FOR THE EVENT REPORTED. ADDENDUM: THIS IS AN ADDENDUM TO THE PREVIOUSLY SUBMITTED MDR TO REPORT ADDITIONAL INFORMATION PROVIDED. AS REPORTED, SEVEN MONTHS POST-IMPLANT, THE PATIENT WITH A MEDICAL HISTORY OF SMALL BOWEL OBSTRUCTION (SBO), DEVELOPED A SBO AND UNDERWENT EXPLORATORY SURGERY, DURING WHICH THE MESH WAS EXPLANTED. THE CLINICIAN HAS ASSESSED THE ADVERSE EVENT TO BE NOT RELATED THE STUDY DEVICE AND POSSIBLY RELATED TO THE INDEX PROCEDURE, HOWEVER, BASED ON THE INFORMATION PROVIDED, NO CONCLUSION CAN BE MADE. 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. H3 OTHER TEXT : NOT RETURNED - MESH EXPLANTED.
AS REPORTED, 11 DAYS POST-IMPLANT OF THE PHASIX MESH, THE PATIENT EXPERIENCED A POSTOPERATIVE HEMATOMA THAT REQUIRED EVACUATION AND STAPLE REMOVAL. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE COURSE AS BEING ¿POSSIBLY¿ RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE; HOWEVER, BASED ON THE INFORMATION PROVIDED, NO CONCLUSION CAN BE MADE. HEMATOMA IS A KNOWN INHERENT RISK OF SURGERY AND IS LISTED IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE (IFU) SUPPLIED WITH THE DEVICE AS A POSSIBLE COMPLICATION. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION, WITH NO INDICATION OF A MANUFACTURING RELATED CAUSE FOR THE EVENT REPORTED. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.
AS REPORTED PER PREVENT CLINICAL TRIAL (B)(6): ON (B)(6) 2021, DURING AN OPEN RELAPAROTOMY OSTOMY PROCEDURE, THE STUDY PATIENT WAS IMPLANTED WITH A BARD/DAVOL PHASIX MESH WHICH WAS TRIMMED AND PLACED IN AN ONLAY FASHION. SKIN INCISIONS ( SIZE-18CM) WERE MADE STRAIGHT NEAR THE EPIGASTRIC AND UMBILICAL REGION. MIDLINE FASCIA CLOSURE WAS ACHIEVED USING A NON-BARD/DAVOL SINGLE SUTURE, IN A RUNNING STITCH TECHNIQUE. ALSO, AN ABSORBABLE 1-PDS SUTURE WAS USED FOR SECURING THE MESH AND FINAL SKIN CLOSURE WAS ACHIEVED WITH STAPLES. AS REPORTED, THERE WAS NO ACTIVE SKIN PATHOLOGY AT THE TIME OF IMPLANT AND ANTIBIOTICS WERE ADMINISTERED PERI-OPERATIVELY; THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2021. AS REPORTED, ON (B)(6) 2021, THE STUDY PATIENT WAS DIAGNOSED WITH A HEMATOMA THAT REQUIRED STAPLE REMOVAL. THE SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS ADMINISTERED VANCOMYCIN (750MG) EVERY 12 HRS. ON ADMISSION AND SWITCHED TO PO AUGMENTIN ON ADMIT DAY. AS REPORTED, THE HEMATOMA WAS EVACUATED BEDSIDE IN THE EMERGENCY DEPARTMENT. CULTURE WAS NOT TAKEN. THE STAPLES WERE REMOVED AT THE LOWER INCISION AND THE STUDY PATIENT WAS DISCHARGED HOME WITH THREE TIMES WEEKLY DRESSING CHANGES WITH AQUACEL AG PACKING WITH HOME HEALTH. AS REPORTED, THE PATIENT IS TOLERATING THE PACKING CHANGES AND REPORTS SOME DRAINAGE FROM THE AREA, BUT IS CONTROLLED WITH DRESSING. THE STUDY CLINICIAN HAS ASSESSED THE REPORTED ADVERSE EVENT (AE) AS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE. THE ADVERSE EVENT HAS BEEN ASSESSED TO BE OF MILD SEVERITY. ADDENDUM PER EMAIL NOTIFICATION FROM CLINICAL TRIAL SITE: ON (B)(6) 2022, THE PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION (SBO) AND UNDERWENT AN EXPLORATORY LAPAROTOMY WITH COMPLETE REMOVAL OF THE PHASIX MESH. AS REPORTED, THIS ADVERSE EVENT HAS BEEN ASSESSED PER THE STUDY CLINICIAN AS MODERATE IN SEVERITY AND NOT RECOVERED/NOT RESOLVED. THE STUDY CLINICIAN HAS ASSESSED THE ADVERSE EVENT TO BE NOT RELATED THE STUDY DEVICE AND POSSIBLY RELATED TO THE INDEX PROCEDURE. THE REPORTED EVENT HAS BEEN ASSESSED TO MEET THE DEFINITION OF A SERIOUS ADVERSE EVENT (SAE). THE REPORTED EVENT DOES NOT MEET THE DEFINITION OF AN UNIDENTIFIED ADVERSE DEVICE EVENT (UADE).
AS REPORTED PER PREVENT CLINICAL TRIAL (B)(4): ON (B)(6) 2021, DURING AN OPEN RELAPAROTOMY OSTOMY PROCEDURE, THE STUDY PATIENT WAS IMPLANTED WITH A BARD/DAVOL PHASIX MESH WHICH WAS TRIMMED AND PLACED IN AN ONLAY FASHION. SKIN INCISIONS ( SIZE-18CM) WERE MADE STRAIGHT NEAR THE EPIGASTRIC AND UMBILICAL REGION. MIDLINE FASCIA CLOSURE WAS ACHIEVED USING A NON-BARD/DAVOL SINGLE SUTURE, IN A RUNNING STITCH TECHNIQUE. ALSO, AN ABSORBABLE 1-PDS SUTURE WAS USED FOR SECURING THE MESH AND FINAL SKIN CLOSURE WAS ACHIEVED WITH STAPLES. AS REPORTED, THERE WAS NO ACTIVE SKIN PATHOLOGY AT THE TIME OF IMPLANT AND ANTIBIOTICS WERE ADMINISTERED PERI-OPERATIVELY; THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2021. AS REPORTED, ON (B)(6) 2021, THE STUDY PATIENT WAS DIAGNOSED WITH A HEMATOMA THAT REQUIRED STAPLE REMOVAL. THE SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS ADMINISTERED VANCOMYCIN (750MG) EVERY 12 HRS. ON ADMISSION AND SWITCHED TO PO AUGMENTIN ON ADMIT DAY. AS REPORTED, THE HEMATOMA WAS EVACUATED BEDSIDE IN THE EMERGENCY DEPARTMENT. CULTURE WAS NOT TAKEN. THE STAPLES WERE REMOVED AT THE LOWER INCISION AND THE STUDY PATIENT WAS DISCHARGED HOME WITH THREE TIMES WEEKLY DRESSING CHANGES WITH AQUACEL AG PACKING WITH HOME HEALTH. AS REPORTED, THE PATIENT IS TOLERATING THE PACKING CHANGES AND REPORTS SOME DRAINAGE FROM THE AREA, BUT IS CONTROLLED WITH DRESSING. THE STUDY CLINICIAN HAS ASSESSED THE REPORTED ADVERSE EVENT (AE) AS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE. THE ADVERSE EVENT HAS BEEN ASSESSED TO BE OF MILD SEVERITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1898074 | PHASIX MESH | SURGICAL MESH | OOD | DAVOL INC., SUB. C.R. BARD, INC. -1213643 | NA | HUDY1470 | 00801741107610 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Female | Required Intervention| H |