FDA Adverse Event
Injury
Summary report: N
S-ROM*SLEEVE PRX ZTT, 18D-LRG
MDR report key: 3423266
·
Received October 22, 2013
Report
- Report Number
- 1818910-2013-31185
- Event Type
- Injury
- Date Received
- October 22, 2013
- Date of Event
- September 16, 2010
- Report Date
- October 10, 2013
- Manufacturer
- 9616671 DEPUY IRELAND
- Product Code
- LPH
- PMA / PMN Number
- PK934412
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODES WX4D21007, 1147539, 1209849, AND 1204177. A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODE 1172080 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 540642 | S-ROM*SLEEVE PRX ZTT, 18D-LRG | SLEEVE | LPH | 9616671 DEPUY IRELAND | 1172080 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |