FDA Adverse Event
Malfunction
Summary report: N
VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE
MDR report key: 3222574
·
Received July 12, 2013
Report
- Report Number
- 2210968-2013-12945
- Event Type
- Malfunction
- Date Received
- July 12, 2013
- Date of Event
- June 26, 2013
- Report Date
- June 27, 2013
- Manufacturer
- ETHICON INC.
- Product Code
- GAM
- PMA / PMN Number
- K032420
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
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.
Additional Manufacturer Narrative · 1
(B)(4): A REPRESENTATIVE SAMPLE WAS RETURNED FOR EVALUATION. THE SAMPLE WAS VISUALLY EVALUATED. NO NEEDLE OR SUTURE DEFECTS WERE NOTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A UTERINE-INCISION DELIVERY ON (B)(6) 2013 AND SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING THE MUSCLE FASCIA. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCE TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 323084 | VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE | SUTURES - ABSORBABLE | GAM | ETHICON INC. | UNK | EL2897 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |