FDA Adverse Event
Injury
Summary report: N
OBTRYX SYSTEM
MDR report key: 3922584
·
Received July 9, 2014
Report
- Report Number
- 3005099803-2014-02492
- Event Type
- Injury
- Date Received
- July 9, 2014
- Report Date
- June 19, 2014
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- OTN
- PMA / PMN Number
- K040787
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GB
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX HALO SYSTEM WAS USED DURING A PROCEDURE ON (B)(6) 2011. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD SULCAL EROSION, GROIN PAIN, REVISION SURGERY AND BURCH COLPOSUSPENSION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 401535 | OBTRYX SYSTEM | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR | OTN | BOSTON SCIENTIFIC - MARLBOROUGH | M0068505001 | 1ML1022804 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |