FDA Adverse Event
Injury
Summary report: N
INTERCEED* (TC7) ABSORBABLE ADHESION BARRIER
MDR report key: 3832650
·
Received May 27, 2014
Report
- Report Number
- 2210968-2014-06654
- Event Type
- Injury
- Date Received
- May 27, 2014
- Date of Event
- May 3, 2014
- Report Date
- May 6, 2014
- Manufacturer
- ETHICON INC.
- Product Code
- MCN
- PMA / PMN Number
- P880047
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY TO TREAT PELVIC PAIN AND UTERINE FIBROIDS AND AN ABSORBABLE ADHESION BARRIER WAS USED. FOUR DAYS AFTER THE PROCEDURE, THE PATIENT PRESENTED WITH A PELVIC ABSCESS DUE TO A LEAK. A DRAIN WAS PLACED AND ANTIBIOTICS WERE STARTED. THE CURRENT CONDITION OF THE PATIENT WAS REPORTED AS STABLE WITH THE DRAIN IN PLACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310536 | INTERCEED* (TC7) ABSORBABLE ADHESION BARRIER | BARRIER, ABSORBABLE, ADHESION | MCN | ETHICON INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |