MAUDE Adverse Event Report: ETHICON INC. INTERCEED* (TC7) ABSORBABLE ADHESION BARRIER; BARRIER, ABSORBABLE, ADHESION

Catalog Number 4350

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Adhesion(s) (1695); Fever (1858); Inflammation (1932); Irritation (1941); Pain (1994); Reaction (2414); Numbness (2415); No Code Available (3191)

Event Date 08/16/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Inflammatory reaction occurred.The actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: batch# kbb2252, batch# kcb2541, batch# kcb3271, batch# kdb3642, batch# kdb3643, batch# kdb3901.In addition, a review of the batch manufacturing records for the possible batch numbers was conducted and the batches met all finished goods release criteria.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.The patient demographic info: weight and bmi at the time of index procedure.What is the actual product lot number of the specific device used during the event? what is physician¿s opinion as to the etiology of or contributing factors to this event? has any medical intervention been provided for the ovarian and peritoneal irritation symptoms? what is the patient¿s current status?.

Event Description

It was reported that the patient underwent a laparoscopic oophorocystectomy procedure on (b)(6) 2016 and absorbable adhesion barrier was applied on the posterior surface of the uterus or on the entire left ovary.After the procedure, abdominal pain started and persisted.Then, on (b)(6) 2016, the patient experienced inflammatory reaction in the peritoneal cavity with fever in addition to ongoing abdominal pain.On (b)(6) 2016 the re-operation was performed and absorbable adhesion barrier had already become gelatinized.Since it was very difficult to remove absorbable adhesion barrier from the patient, intraperitoneal irrigation was also done.After the reoperation, inflammatory reaction and fever were subsided.However, ovarian and peritoneal irritation symptoms have been persisted since the reoperation.Because the patient has not been tolerated to any po intake since the reoperation, she is currently hospitalized.It was also reported that the ascitic fluid electrolytes level was unremarkable and the culture of post-operative drained exudate showed no sign of infection.The doctor opined that one of the contributing factors to this event might be due to absorbable adhesion barrier.Additional information has been requested.

Manufacturer Narrative

It was reported that it has been a month and a week since the device was used in the index procedure.Since the patient still has dull pain in the posterior uterus and the left ovary, she is not tolerated with po intake.Additional collection of blood sample was done and its result was unremarkable.On (b)(6) 2016, the open reoperation was done for the adhesion check, intraperitoneal irrigation, and direct palpation of the ovary.Although a corticosteroid injection had been given before this reoperation, there was no improvement of her symptoms.While the patient received daily po intake, her weight became less than 40 kg.Even though parenteral nutrition was given to her, it had to be stopped because she reported numbness in her body.During the reoperation, adhesion was confirmed by the surgeon.The patient has not been tolerated with po intake since the reoperation.The cause of abdominal dull pain (ovarian and uterine pain) is still unknown.(b)(4).

• Type of Device: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 5978147
• MDR Text Key: 55668363
• Report Number: 2210968-2016-13885
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• PMA/PMN Number: P880047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 4350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 17 YR