FDA Adverse Event
Malfunction
Summary report: N
NATURA
MDR report key: 8519767
·
Received April 16, 2019
Report
- Report Number
- 9618003-2019-02740
- Event Type
- Malfunction
- Date Received
- April 16, 2019
- Manufacturer
- CONVATEC DOMINICAN REPUBLIC INC
- Product Code
- EXE
- PMA / PMN Number
- EXEMPT
- Report Source
- Manufacturer report
- Reporter Location
- NH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
THE END USER REPORTED THAT THE STARTER HOLE WAS OFF CENTER WHICH IMPACTED HIS WEAR TIME. THERE WAS NO REPORTED HARM. NO FURTHER INFORMATION OR PHOTOGRAPH WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310647 | NATURA | PROTECTOR, OSTOMY | EXE | CONVATEC DOMINICAN REPUBLIC INC | 404592 | 8G01431 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 |