GENTRIX SURGICAL MATRIX PLUS
Report
- Report Number
- 3005920706-2019-00011
- Event Type
- Injury
- Date Received
- June 12, 2019
- Date of Event
- March 26, 2019
- Report Date
- June 24, 2019
- Manufacturer
- ACELL, INC.
- Product Code
- FTM
- PMA / PMN Number
- K182259
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
THIS IS A FOLLOW-UP REPORT FOR ADDITIONAL AND CORRECTED INFORMATION THAT WAS RECEIVED SUBSEQUENT TO THE INITIAL FILING OF THE REPORTED INFECTION POST IMPLANTATION OF THE ACELL DEVICES. THE ACELL DEVICES WERE NOT EXPLANTED AND WERE UTILIZED THE BY THE SURGEON TO AID IN THE FINAL WOUND CLOSURE. THE PATIENT HAD A PRE-EXISTING INFECTION WHEN THE ACELL DEVICES WERE IMPLANTED. THE SURGEON DOES NOT ATTRIBUTE THE PATIENT'S MULTIPLE INFECTIONS TO THE ACELL DEVICES. THE SURGEON IS SATISFIED WITH THE OUTCOME OF THE PATIENT. A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE AS THE LOT AND SERIAL NUMBER WAS NOT PROVIDED BY THE SURGEON. NEVERTHELESS, ALL ACELL DEVICES ARE MANUFACTURED AND DISTRIBUTED STERILE IN COMPLIANCE WITH FDA, STATE, LOCAL LAWS AND REGULATIONS, AND ACELL'S OPERATING PROCEDURES.
THIS IS A FOLLOW-UP REPORT FOR ADDITIONAL AND CORRECTED INFORMATION THAT WAS RECEIVED SUBSEQUENT TO THE INITIAL FILING OF THE REPORTED INFECTION POST IMPLANTATION OF THE ACELL DEVICES. THE ACELL DEVICES WERE NOT EXPLANTED AND WERE UTILIZED THE BY THE SURGEON TO AID IN THE FINAL WOUND CLOSURE. THE PATIENT HAD A PRE-EXISTING INFECTION WHEN THE ACELL DEVICES WERE IMPLANTED. THE SURGEON DOES NOT ATTRIBUTE THE PATIENT'S MULTIPLE INFECTIONS TO THE ACELL DEVICES. THE SURGEON IS SATISFIED WITH THE OUTCOME OF THE PATIENT. A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE AS THE LOT AND SERIAL NUMBER WAS NOT PROVIDED BY THE SURGEON. NEVERTHELESS, ALL ACELL DEVICES ARE MANUFACTURED AND DISTRIBUTED STERILE IN COMPLIANCE WITH FDA, STATE, LOCAL LAWS AND REGULATIONS, AND ACELL'S OPERATING PROCEDURES.
THIS IS A FOLLOW-UP REPORT FOR ADDITIONAL AND CORRECTED INFORMATION THAT WAS RECEIVED SUBSEQUENT TO THE INITIAL FILING OF THE REPORTED INFECTION POST IMPLANTATION OF THE ACELL DEVICES. THE ACELL DEVICES WERE NOT EXPLANTED AND WERE UTILIZED THE BY THE SURGEON TO AID IN THE FINAL WOUND CLOSURE. THE PATIENT HAD A PRE-EXISTING INFECTION WHEN THE ACELL DEVICES WERE IMPLANTED. THE SURGEON DOES NOT ATTRIBUTE THE PATIENT'S MULTIPLE INFECTIONS TO THE ACELL DEVICES. THE SURGEON IS SATISFIED WITH THE OUTCOME OF THE PATIENT. A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE AS THE LOT AND SERIAL NUMBER WAS NOT PROVIDED BY THE SURGEON. NEVERTHELESS, ALL ACELL DEVICES ARE MANUFACTURED AND DISTRIBUTED STERILE IN COMPLIANCE WITH FDA, STATE, LOCAL LAWS AND REGULATIONS, AND ACELL'S OPERATING PROCEDURES.
THIS IS A FOLLOW-UP REPORT FOR ADDITIONAL AND CORRECTED INFORMATION THAT WAS RECEIVED SUBSEQUENT TO THE INITIAL FILING OF THE REPORTED INFECTION POST IMPLANTATION OF THE ACELL DEVICES. THE ACELL DEVICES WERE NOT EXPLANTED AND WERE UTILIZED THE BY THE SURGEON TO AID IN THE FINAL WOUND CLOSURE. THE PATIENT HAD A PRE-EXISTING INFECTION WHEN THE ACELL DEVICES WERE IMPLANTED. THE SURGEON DOES NOT ATTRIBUTE THE PATIENT'S MULTIPLE INFECTIONS TO THE ACELL DEVICES. THE SURGEON IS SATISFIED WITH THE OUTCOME OF THE PATIENT. A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE AS THE LOT AND SERIAL NUMBER WAS NOT PROVIDED BY THE SURGEON. NEVERTHELESS, ALL ACELL DEVICES ARE MANUFACTURED AND DISTRIBUTED STERILE IN COMPLIANCE WITH FDA, STATE, LOCAL LAWS AND REGULATIONS, AND ACELL'S OPERATING PROCEDURES.
THIS IS A FOLLOW-UP REPORT FOR ADDITIONAL AND CORRECTED INFORMATION THAT WAS RECEIVED SUBSEQUENT TO THE INITIAL FILING OF THE REPORTED INFECTION POST IMPLANTATION OF THE ACELL DEVICES. THE ACELL DEVICES WERE NOT EXPLANTED AND WERE UTILIZED THE BY THE SURGEON TO AID IN THE FINAL WOUND CLOSURE. THE PATIENT HAD A PRE-EXISTING INFECTION WHEN THE ACELL DEVICES WERE IMPLANTED. THE SURGEON DOES NOT ATTRIBUTE THE PATIENT'S MULTIPLE INFECTIONS TO THE ACELL DEVICES. THE SURGEON IS SATISFIED WITH THE OUTCOME OF THE PATIENT. A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE AS THE LOT AND SERIAL NUMBER WAS NOT PROVIDED BY THE SURGEON. NEVERTHELESS, ALL ACELL DEVICES ARE MANUFACTURED AND DISTRIBUTED STERILE IN COMPLIANCE WITH FDA, STATE, LOCAL LAWS AND REGULATIONS, AND ACELL'S OPERATING PROCEDURES.
ON (B)(6) 2029, ACELL, INC. WAS NOTIFIED BY PHYSICIAN THAT THEIR PATIENT EXPERIENCED AN INFECTION POST IMPLANTATION OF A NON-ACELL DEVICE ON (B)(6) 2018 FOR FOR ACUTE CHOLECYSTITIS AND INCARCERATED INCISIONAL HERNIA REPAIR OF THE ABDOMINAL WALL. THE NON-ACELL DEVICE WAS EXPLANTED ON (B)(6) 2019 AND ACELL DEVICES WERE IMPLANTED. THE PATIENT HAD AN EXISTING INFECTION WHEN THE ACELL DEVICES WERE IMPLANTED ON (B)(6) 2019. ON (B)(6) 2019 A CT SCAN OF THE PATIENT'S ABDOMEN AND PELVIS SHOWED AN ABDOMINAL WALL ABSCESS POST REMOVAL OF THE PIGTAIL DRAINAGE CATHETER. ON (B)(6) 2019 THE PHYSICIAN CONDUCTED AN ABDOMINAL WOUND EXPLORATION AND DEBRIDEMENT. THE ACELL DEVICES WERE NOT EXPLANTED. MORE ACELL DEVICES WERE APPLIED DURING THE PROCEDURE ON (B)(6) 2019. ON (B)(6) 2019 PHYSICAN CONDUCTED WOUND DEBRIDEMENT, PARTIALLY CLOSURE OF WOUND AND WOUND VAC PLACEMENT. THE ACELL DEVICES WERE NOT EXPLANTED. THE PHYSICIAN DOES NOT ATTRIBUTE THE PATIENT'S MULTIPLE INFECTIONS TO THE ACELL DEVICES.
ON 6/24/19, ACELL, INC. WAS NOTIFIED BY PHYSICIAN THAT THEIR PATIENT EXPERIENCED AN INFECTION POST IMPLANTATION OF A NON-ACELL DEVICE ON (B)(6) 2018 FOR ACUTE CHOLECYSTITIS AND INCARCERATED INCISIONAL HERNIA REPAIR OF THE ABDOMINAL WALL. THE NON-ACELL DEVICE WAS EXPLANTED ON (B)(6) 2019 AND ACELL DEVICES WERE IMPLANTED. THE PATIENT HAD AN EXISTING INFECTION WHEN THE ACELL DEVICES WERE IMPLANTED ON (B)(6) 2019. ON (B)(6) 2019 A CT SCAN OF THE PATIENT'S ABDOMEN AND PELVIS SHOWED AN ABDOMINAL WALL ABSCESS POST REMOVAL OF THE PIGTAIL DRAINAGE CATHETER. ON (B)(6) 2019 THE PHYSICIAN CONDUCTED AN ABDOMINAL WOUND EXPLORATION AND DEBRIDEMENT. THE ACELL DEVICES WERE NOT EXPLANTED. MORE ACELL DEVICES WERE APPLIED DURING THE PROCEDURE ON (B)(6) 2019. ON (B)(6) 2019 PHYSICAN CONDUCTED WOUND DEBRIDEMENT, PARTIALLY CLOSURE OF WOUND AND WOUND VAC PLACEMENT. THE ACELL DEVICES WERE NOT EXPLANTED. THE PHYSICIAN DOES NOT ATTRIBUTE THE PATIENT'S MULTIPLE INFECTIONS TO THE ACELL DEVICES.
ON 6/24/2019, ACELL, INC. WAS NOTIFIED BY PHYSICIAN THAT THEIR PATIENT EXPERIENCED AN INFECTION POST IMPLANTATION OF A NON-ACELL DEVICE ON (B)(6) 2018 FOR FOR ACUTE CHOLECYSTITIS AND INCARCERATED INCISIONAL HERNIA REPAIR OF THE ABDOMINAL WALL. THE NON-ACELL DEVICE WAS EXPLANTED ON (B)(6) 2019 AND ACELL DEVICES WERE IMPLANTED. THE PATIENT HAD AN EXISTING INFECTION WHEN THE ACELL DEVICES WERE IMPLANTED ON (B)(6) 2019. ON (B)(6) 2019 A CT SCAN OF THE PATIENT'S ABDOMEN AND PELVIS SHOWED AN ABDOMINAL WALL ABSCESS POST REMOVAL OF THE PIGTAIL DRAINAGE CATHETER. ON (B)(6) 2019 THE PHYSICIAN CONDUCTED AN ABDOMINAL WOUND EXPLORATION AND DEBRIDEMENT. THE ACELL DEVICES WERE NOT EXPLANTED. MORE ACELL DEVICES WERE APPLIED DURING THE PROCEDURE ON (B)(6) 2019. ON (B)(6) 2019 PHYSICAN CONDUCTED WOUND DEBRIDEMENT, PARTIALLY CLOSURE OF WOUND AND WOUND VAC PLACEMENT. THE ACELL DEVICES WERE NOT EXPLANTED. THE PHYSICIAN DOES NOT ATTRIBUTE THE PATIENT'S MULTIPLE INFECTIONS TO THE ACELL DEVICES.
ON (B)(6) 2019, ACELL, INC. WAS NOTIFIED BY PHYSICIAN THAT THEIR PATIENT EXPERIENCED AN INFECTION POST IMPLANTATION OF A NON-ACELL DEVICE ON (B)(6) 2018 FOR FOR ACUTE CHOLECYSTITIS AND INCARCERATED INCISIONAL HERNIA REPAIR OF THE ABDOMINAL WALL. THE NON-ACELL DEVICE WAS EXPLANTED ON (B)(6) 2019 AND ACELL DEVICES WERE IMPLANTED. THE PATIENT HAD AN EXISTING INFECTION WHEN THE ACELL DEVICES WERE IMPLANTED ON (B)(6) 2019. ON (B)(6) 2019 A CT SCAN OF THE PATIENT'S ABDOMEN AND PELVIS SHOWED AN ABDOMINAL WALL ABSCESS POST REMOVAL OF THE PIGTAIL DRAINAGE CATHETER. ON (B)(6) 2019 THE PHYSICIAN CONDUCTED AN ABDOMINAL WOUND EXPLORATION AND DEBRIDEMENT. THE ACELL DEVICES WERE NOT EXPLANTED. MORE ACELL DEVICES WERE APPLIED DURING THE PROCEDURE ON (B)(6) 2019. ON (B)(6) 2019 PHYSICAN CONDUCTED WOUND DEBRIDEMENT, PARTIALLY CLOSURE OF WOUND AND WOUND VAC PLACEMENT. THE ACELL DEVICES WERE NOT EXPLANTED. THE PHYSICIAN DOES NOT ATTRIBUTE THE PATIENT'S MULTIPLE INFECTIONS TO THE ACELL DEVICES.
ON (B)(6) 2019 ACELL, INC. WAS NOTIFIED BY PHYSICIAN THAT THEIR PATIENT EXPERIENCED AN INFECTION POST IMPLANTATION OF A NON-ACELL DEVICE ON (B)(6) 2018 FOR FOR ACUTE CHOLECYSTITIS AND INCARCERATED INCISIONAL HERNIA REPAIR OF THE ABDOMINAL WALL. THE NON-ACELL DEVICE WAS EXPLANTED ON (B)(6) 2019 AND ACELL DEVICES WERE IMPLANTED. THE PATIENT HAD AN EXISTING INFECTION WHEN THE ACELL DEVICES WERE IMPLANTED ON (B)(6) 2019. ON (B)(6) 2019 A CT SCAN OF THE PATIENT'S ABDOMEN AND PELVIS SHOWED AN ABDOMINAL WALL ABSCESS POST REMOVAL OF THE PIGTAIL DRAINAGE CATHETER. ON 4/11/19 THE PHYSICIAN CONDUCTED AN ABDOMINAL WOUND EXPLORATION AND DEBRIDEMENT. THE ACELL DEVICES WERE NOT EXPLANTED. MORE ACELL DEVICES WERE APPLIED DURING THE PROCEDURE ON 4/11/19. ON 4/15/2019 PHYSICAN CONDUCTED WOUND DEBRIDEMENT, PARTIALLY CLOSURE OF WOUND AND WOUND VAC PLACEMENT. THE ACELL DEVICES WERE NOT EXPLANTED. THE PHYSICIAN DOES NOT ATTRIBUTE THE PATIENT'S MULTIPLE INFECTIONS TO THE ACELL DEVICES.
THIS MDR IS BEING SUBMITTED DUE TO THE REPORTED INFECTION WHICH RESULTED IN EXPLANTATION OF THE ACELL DEVICE. THE SURGEON CANNOT CONFIRM THAT THE ACELL DEVICE WAS THE CAUSE OF THE REPORTED SYMPTOM. THE ACELL DEVICE WAS EXPLANTED, HOWEVER, IT IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE AS THE ACELL DEVICE, LOT AND SERIAL NUMBER WAS NOT PROVIDED BY THE SURGEON. NEVERTHELESS, ALL ACELL DEVICES ARE MANUFACTURED AND DISTRIBUTED STERILE IN COMPLIANCE WITH FDA, STATE, LOCAL LAWS AND REGULATIONS, AND ACELL'S OPERATING PROCEDURES. WE ARE SUBMITTING THIS REPORT NOW, HOWEVER, THE INVESTIGATION IS ONGOING AND MORE INFORMATION WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.
ON 5/14/19, ACELL, INC. WAS NOTIFIED BY A PHYSICIAN THAT THEIR PATIENT DEVELOPED AN INFECTION AFTER APPLICATION OF AN ACELL DEVICE. THE PHYSICIAN STATED HE HAD TO EXPLANT THE DEVICE BECAUSE OF EXCESS DRAINAGE AND AN INFECTION. THE PHYSICIAN WAS UNABLE TO PROVIDE THE DATE OF THE SURGERY, THE ACELL DEVICE USED OR INFORMATION ON THE PATIENT INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 487249 | GENTRIX SURGICAL MATRIX PLUS | GENTRIX SURGICAL MATRIX PLUS | FTM | ACELL, INC. | MSPL1015 | 015696 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other |