FDA Adverse Event
Malfunction
Summary report: N
VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE
MDR report key: 3812450
·
Received May 15, 2014
Report
- Report Number
- 2210968-2014-06141
- Event Type
- Malfunction
- Date Received
- May 15, 2014
- Date of Event
- April 23, 2014
- Report Date
- April 24, 2014
- Manufacturer
- ETHICON INC.
- Product Code
- GAM
- PMA / PMN Number
- K032420
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXCISION OF THE UPPER LOBE ON (B)(6) 2014 AND SUTURE WAS USED ON THE SUBDERMAL TISSUE. DURING USE, THE NEEDLE PULLED OFF OF THE SUTURE TOO EASILY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 291810 | VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE | SUTURE, ABSORBABLE, SYNTHETIC | GAM | ETHICON INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |