FDA Adverse Event
Injury
Summary report: N
PROLENE POLYPROPYLENE SUTURE
MDR report key: 3725116
·
Received April 3, 2014
Report
- Report Number
- 2210968-2014-04248
- Event Type
- Injury
- Date Received
- April 3, 2014
- Date of Event
- February 15, 2013
- Report Date
- March 13, 2014
- Manufacturer
- ETHICON INC.
- Product Code
- GAW
- PMA / PMN Number
- K133356
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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 CARDIOVASCULAR PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE FREE OF THE SUTURE DURING DISTAL ANASTOMOSIS OF AN AORTIC DISSECTION. THE NEEDLE HAS BEEN LODGED IN THE PATIENT'S LEFT ILIAC ARTERY SINCE THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 200987 | PROLENE POLYPROPYLENE SUTURE | SUTURE, NONABSORBABLE | GAW | ETHICON INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |