PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
Report
- Report Number
- 2210968-2022-00165
- Event Type
- Injury
- Date Received
- January 7, 2022
- Date of Event
- October 20, 2020
- Report Date
- January 7, 2022
- Manufacturer
- ETHICON INC.
- Product Code
- NEW
- PMA / PMN Number
- N18331
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. CITATION: JOURNAL OF PLASTIC, RECONSTRUCTIVE & AESTHETIC SURGERY (2021) 74, 981¿986; DOI: HTTPS://DOI.ORG/10.1016/J.BJPS.2020.10.048 . ADDITIONAL INFORMATION: (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED TO DATE. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED: BLAKE DRAIN AND 2¿0 PDS SUTURES CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS (BLAKE DRAIN: MAJOR INFECTION, MINOR INFECTION, PDS SUTURES: MAJOR INFECTION, MINOR INFECTION, HEMATOMA) DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS: BLAKE DRAIN AND 2-0 PDS SUTURES:, USED IN THESE PROCEDURES? THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: JOURNAL OF PLASTIC, RECONSTRUCTIVE & AESTHETIC SURGERY (2021) 74, 981¿986; DOI: HTTPS://DOI.ORG/10.1016/J.BJPS.2020.10.048. RELATED MEDWATCH REPORTS: 2210968-2022-00114.
PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. CITATION: JOURNAL OF PLASTIC, RECONSTRUCTIVE & AESTHETIC SURGERY (2021) 74, 981¿986; DOI: HTTPS://DOI.ORG/10.1016/J.BJPS.2020.10.048 . ADDITIONAL INFORMATION: (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED TO DATE. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED: BLAKE DRAIN AND 2¿0 PDS SUTURES CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS (BLAKE DRAIN: MAJOR INFECTION, MINOR INFECTION, PDS SUTURES: MAJOR INFECTION, MINOR INFECTION, HEMATOMA) DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS: BLAKE DRAIN AND 2-0 PDS SUTURES:, USED IN THESE PROCEDURES? THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: JOURNAL OF PLASTIC, RECONSTRUCTIVE & AESTHETIC SURGERY (2021) 74, 981¿986; DOI: HTTPS://DOI.ORG/10.1016/J.BJPS.2020.10.048. RELATED MEDWATCH REPORTS: 2210968-2022-00114.
TITLE: SINGLE-UNIT TECHNIQUE FOR THE USE OF ACELLULAR DERMAL MATRIX IN IMMEDIATE EXPANDER-BASED BREAST RECONSTRUCTION. THIS REPORT PRESENTS A NOVEL MODIFICATION OF THE ACELLULAR DERMAL MATRIX TECHNIQUE AND ITS OUTCOMES, SIMPLIFYING THE PROCESS AND PROVIDING A MORE ELEGANT METHOD OF CREATING THE PARTIAL SUBMUSCULAR POCKET WITH THE INFEROLATERAL ACELLULAR DERMAL MATRIX SLING. BETWEEN JULY 2015 AND DECEMBER 2018, 62 PATIENTS (108 BREASTS) WHO UNDERWENT IMMEDIATE PLACEMENT OF PARTIAL SUBPECTORAL TISSUE EXPANDERS WITH ACELLULAR DERMAL MATRIX FOR POST-MASTECTOMY BREAST RECONSTRUCTION USING THE NEW TECHNIQUE WERE INCLUDED IN THE STUDY. THE AVERAGE AGE FOR THIS PATIENT GROUP WAS 53 YEARS, WITH A MEAN BMI OF 26.29 KG/M2. DURING THE PROCEDURE, PARACHUTED 2¿0 PDS SUTURES (ETHICON) WERE PASSED ON THE CHEST WALL AT THE DESIRED POSITIONS FOR TAB PLACEMENT AND THE EXPANDER/ ACELLULAR DERMAL MATRIX COMPLEX WAS BROUGHT INTO THE FIELD IN THE PARTIAL SUBPECTORAL POSITION. ONCE IN POSITION, THE PARACHUTE SUTURES WERE SECURED TO THE TABS OF THE TISSUE EXPANDER. TWO 15-FRENCH BLAKE (ETHICON) DRAINS ARE PLACED IN THE BREAST POCKET FOR POST-OPERATIVE DRAINAGE. HEALTHY BLEEDING EDGES OF THE MASTECTOMY SKIN ARE OBTAINED, AND THE SKIN IS CLOSED IN A MULTILAYER FASHION. DRESSINGS AND A POSTOPERATIVE BRA ARE APPLIED, AND DRAINS PLACED TO SUCTION. THE PATIENTS HAD AN AVERAGE FOLLOW-UP OF 18 MONTHS. COMPLICATIONS INCLUDE MAJOR INFECTION (N=9) AND MINOR INFECTION (N=4) AND HEMATOMA (N=2). IN CONCLUSION, THIS SIMPLE BUT EFFECTIVE MODIFICATION IN ACELLULAR DERMAL MATRIX TECHNIQUE IS ASSOCIATED WITH A COMPARABLE COMPLICATION RATE AND ALLOWS FOR GREATER EASE AND CONSISTENCY IN TISSUE EXPANDER PLACEMENT.
TITLE: SINGLE-UNIT TECHNIQUE FOR THE USE OF ACELLULAR DERMAL MATRIX IN IMMEDIATE EXPANDER-BASED BREAST RECONSTRUCTION. THIS REPORT PRESENTS A NOVEL MODIFICATION OF THE ACELLULAR DERMAL MATRIX TECHNIQUE AND ITS OUTCOMES, SIMPLIFYING THE PROCESS AND PROVIDING A MORE ELEGANT METHOD OF CREATING THE PARTIAL SUBMUSCULAR POCKET WITH THE INFEROLATERAL ACELLULAR DERMAL MATRIX SLING. BETWEEN JULY 2015 AND DECEMBER 2018, 62 PATIENTS (108 BREASTS) WHO UNDERWENT IMMEDIATE PLACEMENT OF PARTIAL SUBPECTORAL TISSUE EXPANDERS WITH ACELLULAR DERMAL MATRIX FOR POST-MASTECTOMY BREAST RECONSTRUCTION USING THE NEW TECHNIQUE WERE INCLUDED IN THE STUDY. THE AVERAGE AGE FOR THIS PATIENT GROUP WAS 53 YEARS, WITH A MEAN BMI OF 26.29 KG/M2. DURING THE PROCEDURE, PARACHUTED 2¿0 PDS SUTURES (ETHICON) WERE PASSED ON THE CHEST WALL AT THE DESIRED POSITIONS FOR TAB PLACEMENT AND THE EXPANDER/ ACELLULAR DERMAL MATRIX COMPLEX WAS BROUGHT INTO THE FIELD IN THE PARTIAL SUBPECTORAL POSITION. ONCE IN POSITION, THE PARACHUTE SUTURES WERE SECURED TO THE TABS OF THE TISSUE EXPANDER. TWO 15-FRENCH BLAKE (ETHICON) DRAINS ARE PLACED IN THE BREAST POCKET FOR POST-OPERATIVE DRAINAGE. HEALTHY BLEEDING EDGES OF THE MASTECTOMY SKIN ARE OBTAINED, AND THE SKIN IS CLOSED IN A MULTILAYER FASHION. DRESSINGS AND A POSTOPERATIVE BRA ARE APPLIED, AND DRAINS PLACED TO SUCTION. THE PATIENTS HAD AN AVERAGE FOLLOW-UP OF 18 MONTHS. COMPLICATIONS INCLUDE MAJOR INFECTION (N=9) AND MINOR INFECTION (N=4) AND HEMATOMA (N=2). IN CONCLUSION, THIS SIMPLE BUT EFFECTIVE MODIFICATION IN ACELLULAR DERMAL MATRIX TECHNIQUE IS ASSOCIATED WITH A COMPARABLE COMPLICATION RATE AND ALLOWS FOR GREATER EASE AND CONSISTENCY IN TISSUE EXPANDER PLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2624587 | PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT | SUTURE, SURGICAL, ABSORBABLE | NEW | ETHICON INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |