FDA Adverse Event
Malfunction
Summary report: N
BIOSYN
MDR report key: 6955460
·
Received October 17, 2017
Report
- Report Number
- 9612501-2017-06437
- Event Type
- Malfunction
- Date Received
- October 17, 2017
- Date of Event
- September 1, 2017
- Report Date
- October 24, 2017
- Manufacturer
- DAVIS & GECK CARIBE LTD
- Product Code
- GAM
- UDI-DI
- 20884521031613
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, THE PRODUCT'S NEEDLE WAS RIPPING OFF AND MULTIPLE PRODUCT WAS BROKEN. THE PATIENT INVOLVEMENT WAS UNKNOWN.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, AS PER THE ADDITIONAL INFORMATION RECEIVED, DURING OHE OR NEUTER (OPEN PROCEDURE) WHILE CLOSURE OF THE INCISION (SQ CLOSURE). NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 736574 | BIOSYN | SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | GAM | DAVIS & GECK CARIBE LTD | CM-817 | D7E2191X | 20884521031613 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |