FDA Adverse Event
Injury
Summary report: N
5MM SINGLE USE ABS FIX DEVICE 10 TACKS
MDR report key: 2120448
·
Received June 3, 2011
Report
- Report Number
- 1219930-2011-00469
- Event Type
- Injury
- Date Received
- June 3, 2011
- Date of Event
- November 3, 2010
- Report Date
- May 19, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K091900
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: THE PATIENT HAD LEFT SHOULDER SURGERY PRIOR TO HIS CONSENT TO PARTICIPATE IN THIS STUDY. THE PATIENT EXPERIENCED INCREASED LEFT SHOULDER PAIN POST THE INITIAL SURGERY AND HAD A PARTIAL LEFT SHOULDER REPLACEMENT ON (B)(6) 2011. THE PATIENT WAS D/C ON (B)(6) 2011. THE PATIENT TOOK OXYCODONE 1 TAB PRN FOR PAIN: (B)(6) 2011. THE PATIENT SWITCHED TO TYLENOL 500MG X 2 TABS PRN FOR PAIN: (B)(4) 2011. THE PATIENT EXPERIENCED SEVERE LEFT SHOULDER PAIN ON (B)(6) 2011 WHICH REQUIRED SURGICAL INTERVENTION AND IMPATIENT HOSPITALIZATION/PROLONGED HOSPITALIZATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5MM SINGLE USE ABS FIX DEVICE 10 TACKS | SURGICAL STAPLING DEVICE | GDW | UNITED STATES SURGICAL | N9B437 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Hospitalization| O| R |