FDA Adverse Event
Injury
Summary report: N
ENDOTINE RIBBON
MDR report key: 861526
·
Received June 5, 2007
Report
- Report Number
- 3003644133-2007-00005
- Event Type
- Injury
- Date Received
- June 5, 2007
- Date of Event
- April 27, 2007
- Report Date
- May 17, 2007
- Manufacturer
- COAPT SYSTEMS, INC.
- Product Code
- GAN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PHYSICIAN IS SENDING THE SUBJECT DEVICE TO COAPT FOR EVALUATION. AS SOON AS THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem · 1
JN 2007, THE PATIENT HAD AN ENDOTINE RIBBON PROCEDURE PERFORMED ON THE NECK. THE NEXT MONTH, THE PATIENT RETURNED FOR A FOLLOW-UP VISIT AND THE RIGHT SIDE OF THE NECK APPEARED TO HAVE LOST COSMETIC BENEFIT. THE PHYSICIAN RESUTURED THE DEVICE INTO PLACE UNDER LOCAL ANESTHESIA. DURING THE FOLLOWING WEEK, THE RIGHT SIDE FELL AGAIN. THE PHYSICIAN DETERMINED THAT THE DEVICES SHOULD BE REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTINE RIBBON | ABSORBABLE SURGICAL SUTURE | GAN | COAPT SYSTEMS, INC. | 13005 | 01501 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |