FDA Adverse Event
Malfunction
Summary report: N
MONOCRYL PLUS ANTIBACTERIAL SUTURES
MDR report key: 2971455
·
Received February 21, 2013
Report
- Report Number
- 2210968-2013-01315
- Event Type
- Malfunction
- Date Received
- February 21, 2013
- Date of Event
- November 23, 2012
- Report Date
- January 28, 2013
- Manufacturer
- ETHICON, INC.
- Product Code
- GAM
- PMA / PMN Number
- K050845
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2012 AND SUTURE WAS USED. DURING THE PROCEDURE THE NEEDLE PULLED OFF THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 76019 | MONOCRYL PLUS ANTIBACTERIAL SUTURES | SUTURES, ABSORBABLE | GAM | ETHICON, INC. | NA | EK5GSPV |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |