FDA Adverse Event
Injury
Summary report: N
LAP-BAND ACCESS PORT KIT (UNK SIZE)
MDR report key: 2166974
·
Received July 13, 2011
Report
- Report Number
- 2024601-2011-00551
- Event Type
- Injury
- Date Received
- July 13, 2011
- Date of Event
- December 18, 2010
- Report Date
- June 16, 2011
- Manufacturer
- ALLERGAN
- Product Code
- LTI
- PMA / PMN Number
- P000008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
MEDWATCH SENT TO FDA ON. 08/23/2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 120364 | LAP-BAND ACCESS PORT KIT (UNK SIZE) | LTI | ALLERGAN | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Female | Required Intervention |