VCL+ UD 27IN 5-0 S/A TF
Report
- Report Number
- 2210968-2022-00803
- Event Type
- Malfunction
- Date Received
- February 2, 2022
- Date of Event
- January 7, 2022
- Report Date
- April 18, 2022
- Manufacturer
- ETHICON INC.
- Product Code
- GAM
- UDI-DI
- 10705031053199
- PMA / PMN Number
- K032420
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: WHAT IS THE PROCEDURE & EVENT DATE? WHAT WAS USED TO COMPLETE THE PROCEDURE? WHAT WAS USED TO COMPLETE THE PROCEDURE? HOW MANY DEVICES PRESENT THE ISSUE? PLEASE CONFIRM. THE 19 PIECES TO RETURN ARE JUST SAMPLES OR DID THESE 19 PIECES PRESENT THE ISSUE? PLEASE CLARIFY HOW MANY PIECES PRESENT PULL OFF SUTURE NEEDLE AND HOW MANY SUTURES PRESENT THE SURFACE ISSUE (SOFTER THAN NORMAL)? PLEASE CONFIRM. DEVICE RETURN FOLLOW UP. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. TRADE NAME - IRGACARE ACTIVE INGREDIENT(S)- TRICLOSAN DOSAGE FORM - SUTURE/SOLID/PARENTERAL STRENGTH -= 275 ¿G /M RELATED TO: 2210968-2022-00801, AND 2210968-2022-00802.
PRODUCT COMPLAINT NUMBER: (B)(4) DATE SENT TO THE FDA: 3/3/2022. H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. ADDITIONAL INFORMATION: D3 THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WHAT IS THE PROCEDURE & EVENT DATE?: FEMALE TO MALE ON 7 JAN 2022 WHAT WAS USED TO COMPLETE THE PROCEDURE?: YES. HOW MANY DEVICES PRESENT THE ISSUE? PLEASE CONFIRM: THE SUTURE ARE TORN 3 EA. THE 19 PIECES TO RETURN ARE JUST SAMPLES OR DID THESE 19 PIECES PRESENT THE ISSUE?: PRESENT THE ISSUE BECAUSE THE SURGEON IS NOT CONFIDENT ABOUT SUTURE IN SAME LOT.( IT TORN 3 EA) PLEASE CLARIFY HOW MANY PIECES PRESENT PULL OFF SUTURE NEEDLE AND HOW MANY SUTURES PRESENT THE SURFACE ISSUE (SOFTER THAN NORMAL)? PLEASE CONFIRM: 3 EA. THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. TRADE NAME - IRGACARE ACTIVE INGREDIENT(S)- TRICLOSAN DOSAGE FORM - SUTURE/SOLID/PARENTERAL STRENGTH -= 275 G/M. RELATED TO: 2210968-2022-00801, 2210968-2022-00802.
PRODUCT COMPLAINT #(B)(4). DATE SENT TO THE FDA: 4/18/2022. THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION: D9, H3, H6. H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND. H3 INVESTIGATION SUMMARY: ONE OPENED BOX WITH FIFTEEN OF PRODUCT CODE VCP433H WAS RETURNED TO ETHICON INC FOR ANALYSIS WITH THE PACKAGING CLOSED. UPON INITIAL INSPECTION, OF THE SAMPLES, NO EXTERNAL DAMAGES WERE OBSERVED ON THE PACKETS. IN ORDER TO EVALUATE THE CONDITIONS OF THE RETURNED SAMPLES, THIRTEEN PACKETS WERE OPENED, AND NO DEFECTS WERE DETECTED. THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG THE STRAND TO DETECT ANY ISSUE RELATED TO TEAR DAMAGE OR BREAKAGE SUTURE, AND NO DEFECTS WERE OBSERVED DURING EVALUATION. A FUNCTIONAL TEST WAS PERFORMED USING AN INSTRON AND THE TENSILE STRENGTH FORCE WAS ABOVE THE MINIMUM REQUIREMENT. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DEFECT NOTED. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED, AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH. AS PART OF ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. TRADE NAME - IRGACARE. ACTIVE INGREDIENT(S)- TRICLOSAN. DOSAGE FORM - SUTURE/SOLID/PARENTERAL. STRENGTH -= 275 G /M. RELATED TO: 2210968-2022-00801, 2210968-2022-00802, 2210968-2022-00803.
IT WAS REPORTED THAT A PATIENT UNDERWENT A SEX REASSIGNMENT SURGERY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE, IT WAS ALSO SOFTER THAN USUAL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1812649 | VCL+ UD 27IN 5-0 S/A TF | SUTURE, ABSORBABLE, SYNTHETIC | GAM | ETHICON INC. | VCP433H | QJMXEU | 10705031053199 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |