FDA Adverse Event
Malfunction
Summary report: N
ROCHESTER MEC WIDEBAND M 100BX
MDR report key: 6659920
·
Received June 22, 2017
Report
- Report Number
- 1018233-2017-03249
- Event Type
- Malfunction
- Date Received
- June 22, 2017
- Report Date
- July 11, 2017
- Manufacturer
- DAVOL SURGICAL INNOVATIONS -9616067
- Product Code
- NNX
- UDI-DI
- 00801741070983
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
Additional Manufacturer Narrative · 1
UPON FURTHER REVIEW, BARD MEDICAL HAS DETERMINED THAT THIS MDR WAS INITIALLY REPORTED IN ERROR ON A 3500A FORM. ACCORDING TO BARD MEDICAL DIVISION'S REPORTABILITY GUIDELINES THE EVENT IS A NON-REPORTABLE EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DRAINAGE HOLE OF THE DEVICE HAD NOT BEEN PUNCHED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DRAINAGE HOLE OF THE DEVICE HAD NOT BEEN PUNCHED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 442365 | ROCHESTER MEC WIDEBAND M 100BX | MEC | NNX | DAVOL SURGICAL INNOVATIONS -9616067 | JUAY0418 | 00801741070983 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |