FDA Adverse Event
Malfunction
Summary report: N
MONOCRYL PLUS ANTIBACTERIAL SUTURES
MDR report key: 3033200
·
Received April 3, 2013
Report
- Report Number
- 2210968-2013-03386
- Event Type
- Malfunction
- Date Received
- April 3, 2013
- Date of Event
- March 1, 2013
- Report Date
- March 12, 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 IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, 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.
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 OF THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136694 | MONOCRYL PLUS ANTIBACTERIAL SUTURES | SUTURES, ABSORBABLE | GAM | ETHICON, INC. | NA | EK5BCKV |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |