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 2020-03-26 for GYNECARE INTERCEED 5INX6IN 4350XL manufactured by Ethicon Inc..
[186813534]
(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: were pre-existing adhesion noted during the procedure? No further information is available. How were post-procedural adhesions confirmed? Location and severity? During a reoperation, it was observed that adhesion had occurred at the area where the interceed had been applied. (just under the abdominal wall. ) how were adhesions treated? No further information is available. What was a reason for reoperation on (b)(6) 2019? No further information is available. What is physician? S opinion as to the etiology of or contributing factors to this event? The surgeon commented that there is no particular difference from the general case. The only difference is that reoperation was performed in a short period of 2 weeks. The patient is slender figure. Celecox (cough medicine) was used postoperatively. What is the patient's current status? The patient has been discharged from the hospital. Product lot number? The lot number is unknown. We will update the note, if we get the additional information.
Patient Sequence No: 1, Text Type: N, H10
[186813535]
It was reported that the patient underwent an open rectal cancer surgery and peritoneal dissemination surgery on (b)(6) 2019 and the absorbable adhesive barrier was applied under the abdominal wall. On (b)(6) 2019, during a reoperation, it was observed that adhesion had occurred at the area where the absorbable adhesive barrier had been applied. The condition of the adhesion was sticky and hard. The surgeon opined that there is no particular difference from the general case. The only difference is that reoperation was performed in a short period of 2 weeks. The patient is slender figure and celecox/cough medicine was used postoperatively. The patient has been discharged from the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02410 |
| MDR Report Key | 9887182 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-04 |
| Date of Event | 2019-12-09 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-26 |
| 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 | 2020-03-26 |
| 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 | 2020-03-26 |