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 2019-05-10 for INTERCEED* XL (TC7) 4350XL manufactured by Ethicon Inc..
[144746951]
(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: lot number is unknown, please confirm, only provide if the exact lot is available? Unknown. Date of the procedure? Unknown. Onset of ""infection""? Type of infection? Unknown. The diagnosis and indication for the index surgical procedure? Unknown. It was reported that the infection may be due to not using a wound retractor. Please elaborate for example did not using the retractor result in unexpected injury to underlying tissue due to visibility? Unknown. Does the surgeon believe that the infection was as result of the interceed if not please indicated the etiology of the infection for example anastomotic leak or comorbid conditions? Unknown. Did the patient receive any medical or surgical intervention as a result of the reported infection? Unknown. If yes to question 6, please elaborate on the intervention implemented? How is the patient doing at this time? The patient has been recovered after that. Patient demographics: age, gender, weight, bmi at the time of index procedure, relevant history? Unknown.
Patient Sequence No: 1, Text Type: N, H10
[144746952]
It was reported that the patient underwent a laparoscopic distal gastrectomy on unknown date and the absorbable adhesion barrier was placed between the peritoneum and organs just below the umbilical region of the abdominal wall. The patient experienced infection and the surgeon opined that it may be due to not using a wound retractor. It was confirmed by ct scan that the shape of infection site was the same as the shape of absorbable adhesion barrier. The patient has been recovered after that. No further information is provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-81284 |
| MDR Report Key | 8601155 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-10 |
| Date of Report | 2019-04-17 |
| Date of Event | 2019-04-06 |
| Date Mfgr Received | 2019-05-10 |
| Date Added to Maude | 2019-05-10 |
| 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 | DARLENE KYLE |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182792 |
| Manufacturer G1 | ETHICON INC.-SAN LORENZO PR |
| Manufacturer Street | 982 ROAD 183 KM 8.3 |
| Manufacturer City | SAN LORENZO PR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERCEED* XL (TC7) |
| Generic Name | BARRIER, ABSORBABLE, ADHESION |
| Product Code | MCN |
| Date Received | 2019-05-10 |
| Catalog Number | 4350XL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-10 |