FDA Adverse Event
Injury
Summary report: N
SURGICEL NU-KNIT HEMOSTAT
MDR report key: 3212838
·
Received July 9, 2013
Report
- Report Number
- 2210968-2013-12573
- Event Type
- Injury
- Date Received
- July 9, 2013
- Report Date
- June 19, 2013
- Manufacturer
- ETHICON INC.
- Product Code
- LMF
- PMA / PMN Number
- N12159
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION: 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 IN AN ARTICLE THAT A PATIENT UNDERWENT A GASTRIC BYPASS PROCEDURE ON AN UNKNOWN DATE AND AN ABSORBABLE HEMOSTAT WAS USED ALONG WITH PERI-STRIPS. THE PATIENT EXPERIENCED A HEMORRHAGE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313641 | SURGICEL NU-KNIT HEMOSTAT | HEMOSTATIC AGENT, ABSORBABLE | LMF | ETHICON INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | PERI-STRIPS |