FDA Adverse Event
Malfunction
Summary report: N
COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)
MDR report key: 2860755
·
Received December 6, 2012
Report
- Report Number
- 2210968-2012-07931
- Event Type
- Malfunction
- Date Received
- December 6, 2012
- Date of Event
- November 14, 2012
- Report Date
- November 14, 2012
- Manufacturer
- ETHICON, INC.
- Product Code
- GAM
- PMA / PMN Number
- K032420
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION: 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.
Additional Manufacturer Narrative · 1
(B)(4). 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 A CESAREAN SECTION ON (B)(6) 2012 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF THE SUTURE. THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) | SUTURE, ABSORBABLE | GAM | ETHICON, INC. | NA | EK2353 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |