FDA Adverse Event
Injury
Summary report: N
UPHOLD? LITE
MDR report key: 3914145
·
Received July 3, 2014
Report
- Report Number
- 3005099803-2014-02500
- Event Type
- Injury
- Date Received
- July 3, 2014
- Date of Event
- October 3, 2013
- Report Date
- June 18, 2014
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- OTP
- PMA / PMN Number
- K122459
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ADDITIONAL DEVICE INFO: THE LOT NUMBER IS NOT KNOWN PER THE COMPLAINANT; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD¿ LITE MESH WAS USED IN A PROCEDURE PERFORMED ON (B)(6), 2013. ACCORDING TO THE COMPLAINANT, THERE WAS DIFFICULTY RETRIEVING SUTURE LEADERS ON RIGHT SIDE; SUTURE CUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 390831 | UPHOLD? LITE | MESH, SURGICAL, SYNTHETIC | OTP | BOSTON SCIENTIFIC - MARLBOROUGH | M0068318170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |