FDA Adverse Event
Injury
Summary report: N
GALASHAPE 3D
MDR report key: 7024727
·
Received November 13, 2017
Report
- Report Number
- 3005670760-2017-00015
- Event Type
- Injury
- Date Received
- November 13, 2017
- Date of Event
- May 8, 2017
- Report Date
- September 18, 2017
- Manufacturer
- TEPHA, INC.
- Product Code
- OOD
- UDI-DI
- 00855920006195
- PMA / PMN Number
- K140533
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IMPLANT DATE ON (B)(6) 2017, EXPLANT DATE ON (B)(6) 2017; PHYSICIAN PERFORMED A CULTURE OF THE INFECTED TISSUE AND CONFIRMED GROWTH OF PSEUDOMONAS AERUGINOSA. REVIEW OF DHR (DEVICE HISTORY RECORD) ON PART NUMBER 100042-06, LOT NUMBER 160486 RESULTED IN VERIFICATION THAT THERE WERE NO NON-CONFORMITIES DOCUMENTED FOR THIS LOT. THE STERILIZATION CYCLE REPORT WAS REVIEWED AND THE CYCLE MET ALL ACCEPTANCE CRITERIA.
Description of Event or Problem · 1
INFECTION OF BREAST, REQUIRING REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 804445 | GALASHAPE 3D | GALAFLEX MESH, PRODUCT CODE: OOD | OOD | TEPHA, INC. | 100042-06 | 160486 | 00855920006195 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |