MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-23 for GYNECARE INTERCEED 5INX6IN 4350XL manufactured by Ethicon Inc..
[186526184]
(b)(4). To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent. Additional information was requested, and the following was obtained: name of the initial procedure on (b)(6) 2020? Laparoscopic inspection was performed on that date. Were there any intra-complications? No further information is available. Where were two interceeds applied? Location details? Two sheets of 4350xl were applied over a wide area, including the wound and the site of adhesion detachment, omentum, fat, and small intestine. Any concurrent procedures? No further information is available. Other relevant patient comorbidities/concomitant medications? No further information is available. What was an indication for the ((b)(6)) re-operation? Scheduled robot-assisted laparoscopic gastrectomy. Surgical findings of re-operation? It was found that there was adhesion on the area to which the interceeds were placed on (b)(6). The level of adhesion was worse/stronger than that seen on (b)(6). How were adhesions treated? The adhesion was separated. No anti-adhesion material was used. What is physician? S opinion as to the etiology of or contributing factors to these events? No further information is available. What is the patient's current status after re-operation (b)(6) 2020? No problem. The patient demographic info: age, gender, weight, bmi at the time of index procedure no further information is available. Product lot number? The lot number is unknown. The additional information: the adhesion observed at the time of the operation on 2/25 was a strong adhesion to the abdominal wall with the entire application site. When the trocar could not be punctured at the time of puncturing the trocar, a strong adhesion was confirmed. Adverse event regarding 1st sheet of absorbable adhesive barrier applied on (b)(6) 2020 was submitted via medwatch 2210968-2020-02277.
Patient Sequence No: 1, Text Type: N, H10
[186526185]
It was reported that the patient underwent a laparoscopic inspection procedure on (b)(6) 2020 due to adhesion, and after the adhesion was separated, the absorbable adhesive barrier was placed over a wide area, including the wound and the site of adhesion detachment, omentum, fat, and small intestine. There was no excessive bleeding; the absorbable adhesive barrier migration was observed. On (b)(6) 2020, a scheduled robot-assisted laparoscopic gastrectomy reoperation was performed. It was found that there was adhesion on the area to which the absorbable adhesive barrier was placed on (b)(6) 2020. The level of adhesion was worse/stronger than that seen on (b)(6) 2020. The adhesion observed at the time of the operation on (b)(6) 2020 was a strong adhesion to the abdominal wall with the entire application site. It was also reported that when the trocar could not be punctured at the time of puncturing the trocar, a strong adhesion was confirmed. The patient? S current status after re-operation is with no problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02278 |
| MDR Report Key | 9865665 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-23 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | ETHICON INC.-SAN LORENZO PR |
| Manufacturer Street | 982 ROAD 183 KM 8.3 |
| Manufacturer City | SAN LORENZO PR |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GYNECARE INTERCEED 5INX6IN |
| Generic Name | BARRIER, ABSORBABLE, ADHESION |
| Product Code | MCN |
| Date Received | 2020-03-23 |
| Model Number | 4350XL |
| Catalog Number | 4350XL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-23 |