FDA Adverse Event
Injury
Summary report: N
PROTACK 5MM INSTRUMENT
MDR report key: 2120453
·
Received June 3, 2011
Report
- Report Number
- 2647580-2011-00376
- Event Type
- Injury
- Date Received
- June 3, 2011
- Date of Event
- February 4, 2009
- Report Date
- May 2, 2011
- Manufacturer
- USSC PUERTO RICO
- Product Code
- KOG
- PMA / PMN Number
- K963999
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: LAB RIGHT INGUINAL HERNIA. ACCORDING TO THE REPORTER: THE PATIENT UNDERWENT A LAPAROSCOPIC RIGHT INGUINAL HERNIA PROCEDURE FOR TREATMENT OF A HERNIA. THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PATIENT EXPERIENCED PROLONGED HOSPITALIZATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTACK 5MM INSTRUMENT | DISPOSABLE SURGICAL STAPLER | KOG | USSC PUERTO RICO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |