J-VAC RESERVOIR UNKNOWN PRODUCT

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A TUMMY TUCK SURGERY ON AN UNKNOWN DATE AND A RESERVOIR WAS CONNECTED TO A DRAIN. THE RESERVOIR WAS NOT WORKING. THE PATIENT DEVELOPED A SEROMA, 650ML, BASICALLY FORCED IT WAY OPEN WOUND, INFECTION FROM IT, TRAUMA TO LYMPHATIC SYSTEM, TOLD SURGEON. ADDITIONAL INFORMATION REQUESTED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. 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. 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: DID THE PATIENT EXPERIENCE A WOUND DEHISCENCE? IF YES, HOW WAS IT MANAGED? PLEASE DESCRIBE THE PATIENT MANIFESTATIONS OF THE REPORTED INFECTION (LOCATION, SEVERITY, APPEARANCE, SYSTEMIC OR LOCAL INFECTION). PLEASE PROVIDE THE ONSET DATE/TIME OF INFECTION FROM THE INITIAL SURGICAL PROCEDURE. WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? WERE CULTURES PERFORMED? IF SO, PLEASE PROVIDE THE RESULTS. IS A PHOTO AVAILABLE OF THE PATIENT¿S DEHISCENCE/INFECTION? WHAT WAS THE PROCEDURE DATE? WERE ANY CONCOMITANT PROCEDURES PERFORMED? WERE THERE ANY INTRA-OPERATIVE COMPLICATIONS? IF SO, WHAT WERE THEY? WERE ANY PRE-OP CLEANSING PROCEDURES CHANGED RECENTLY? IF YES, PLEASE DESCRIBE WHAT DATE /DAY POST OP WAS THE DEHISCENCE NOTED? WAS ANY PRESCRIPTION STRENGTH MEDICATION PRESCRIBED? PLEASE SPECIFY? WAS ANY SURGICAL INTERVENTION PERFORMED? WHAT IS THE ALLEGED DEFICIENCY OF THE J-VAC RESERVOIR? WHAT WAS THE DATE OF FIRST ACTIVATION? HOW WAS THE PRODUCT FUNCTION VERIFIED FOLLOWING THE FIRST ACTIVATION? WHO MONITORED THE DRAINAGE AND HOW OFTEN? WHEN WAS THE MALFUNCTION FIRST NOTED? WAS LEAKAGE DETECTED? IF SO, WHERE? WAS ANOTHER PRODUCT USED? WAS THE ANTI-REFLUX VALVE FOUND DETACHED/CLOSED/OPENED? DID THE RESERVOIR INFLATE QUICKLY UPON ACTIVATION? WAS THERE A FAILURE OF THE LOCKING PLATE MECHANISM? DID THE RESERVOIR COME IN CONTACT WITH SURGICAL INSTRUMENTS, SURGICAL NEEDLES, SUTURES, SHARP OBJECTS AT ANY TIME? PATIENT DEMOGRAPHICS: INITIALS / ID, GENDER, AGE OR DATE OF BIRTH, BMI? PATIENT PRE-EXISTING MEDICAL CONDITIONS (IE. ALLERGIES, HISTORY OF REACTIONS)? PRODUCT CODE AND LOT NUMBER OF PRODUCT USED? CURRENT PATIENT STATUS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WILL PRODUCT BE RETURNED FOR EVALUATION? IF SO, PLEASE PROVIDE THE RETURN DATE AND TRACKING INFORMATION.