FDA Adverse Event
Injury
Summary report: N
PERMACOL PRODUCT
MDR report key: 3940778
·
Received July 2, 2014
Report
- Report Number
- 9617613-2014-00108
- Event Type
- Injury
- Date Received
- July 2, 2014
- Report Date
- June 9, 2014
- Manufacturer
- COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC
- Product Code
- FTL
- PMA / PMN Number
- K992556
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: ELAPR. ACCORDING TO THE REPORTER: IN AN ABSTRACT ENTITLED "THE USE OF PORCINE COLLAGEN MESH TO PREVENT PERIANAL HERNIATION AFTER EXTRALEVATOR LAPAROSCOPIC ABDOMINOPERINEAL RESECTION OF THE RECTUM (ELAPR): A CASE SERIES" WRITTEN ANIL BAGUL ET AL. PUBLISHED INTERNATIONAL JOURNAL OF SURGERY 11 (2013) 589-685. THIS ABSTRACT PRESENTED A STUDY OF 23 PATIENTS WHO UNDERWENT ELAPR AND HAD PORCINE MESH IMPLANTED TO PREVENT PERINEAL HERNIATION. PERINEAL COMPLICATIONS SEEN WERE 4 SUPERFICIAL WOUND BREAKDOWN WITH CONSEQUENT DELAYED HEALING AND 6 PERSISTENT PERINEAL DISCHARGE. ONE PATIENT HAD A HERNIA OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 385320 | PERMACOL PRODUCT | PERMACOL MESH | FTL | COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |