FDA Adverse Event
Injury
Summary report: N
MAX GR 1X24 CV310 6/0 DA 1
MDR report key: 5697317
·
Received June 3, 2016
Report
- Report Number
- 1219930-2016-00584
- Event Type
- Injury
- Date Received
- June 3, 2016
- Report Date
- May 11, 2016
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL A DIVISON
- Product Code
- GAM
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ADDITIONAL ATTEMPTS TO OBTAIN INFORMATION AND THE DEVICE HAVE BEEN MADE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH NEW DETAILS IF THEY BECOME AVAILABLE.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, THE SUTURE BROKE AFTER PATIENT WENT HOME AND REQUIRED RE-OPERATION DUE TO DEHISCENCE. ORIGINAL PROCEDURE WAS PEDIATRIC OPEN HEART SURGERY. THE CURRENT PATIENT STATUS IS FINE. THIS DID RESULT IN TISSUE DAMAGE/PATIENT INJURY - THE PATIENT NEEDED TO HAVE RE-OPERATION. TO CORRECT THIS CONDITION, THE PATIENT UNDERWENT REOPERATION TO REPAIR THE SUTURE THAT BROKE POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 352751 | MAX GR 1X24 CV310 6/0 DA 1 | SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | GAM | COVIDIEN, FORMERLY US SURGICAL A DIVISON | 8886613911 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |