FDA Adverse Event
Malfunction
Summary report: N
PRONOVA BLUE MONO POLY(HEXAFLUOROPROPYLENE)SUTURE
MDR report key: 3122791
·
Received May 21, 2013
Report
- Report Number
- 2210968-2013-05755
- Event Type
- Malfunction
- Date Received
- May 21, 2013
- Date of Event
- April 26, 2013
- Report Date
- May 2, 2013
- Manufacturer
- ETHICON, INC.
- Product Code
- GAW
- PMA / PMN Number
- K001625
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. THEY WERE VISUALLY AND FUNCTIONALLY EXAMINED FOR TENSILE STRENGTH AND THEY MET THE REQUIREMENTS.
Additional Manufacturer Narrative · 1
(B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED. DURING THE PROCEDURE THE NEEDLE PULLED OFF THE SUTURE. THE CASE WAS COMPLETED WITH A LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 223834 | PRONOVA BLUE MONO POLY(HEXAFLUOROPROPYLENE)SUTURE | SUTURE, NON ABSORBABLE | GAW | ETHICON, INC. | NA | DMR813 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |