FDA Adverse Event
Malfunction
Summary report: N
MONOCRYL PLUS SUTURE
MDR report key: 3212907
·
Received July 9, 2013
Report
- Report Number
- 2210968-2013-12581
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- June 20, 2013
- Report Date
- June 21, 2013
- Manufacturer
- ETHICON INC.
- Product Code
- GAM
- PMA / PMN Number
- K050845
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.
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 PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF THE SUTURE. A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312047 | MONOCRYL PLUS SUTURE | SUTURES - ABSORBABLE | GAM | ETHICON INC. | GA6220 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |