FDA Adverse Event
Malfunction
Summary report: N
VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE
MDR report key: 3931659
·
Received July 14, 2014
Report
- Report Number
- 2210968-2014-09071
- Event Type
- Malfunction
- Date Received
- July 14, 2014
- Date of Event
- June 20, 2014
- Report Date
- June 22, 2014
- Manufacturer
- ETHICON INC.
- Product Code
- GAM
- PMA / PMN Number
- K032420
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Additional Manufacturer Narrative · 1
(B)(4). TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2014 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING KNOTTING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 410891 | VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE | SUTURE, ABSORBABLE, SYNTHETIC | GAM | ETHICON INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |