FDA Adverse Event
Injury
Summary report: N
SURGICAL STAINLESS STEEL SUTURE
MDR report key: 1725621
·
Received June 11, 2010
Report
- Report Number
- 2210968-2010-00664
- Event Type
- Injury
- Date Received
- June 11, 2010
- Date of Event
- October 10, 2009
- Report Date
- May 14, 2010
- Manufacturer
- ETHICON, INC.
- Product Code
- GAQ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B) (4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, 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 PT UNDERWENT A CARDIOVASCULAR SURGICAL PROCEDURE ON (B) (6) 2009. AFTER THE PROCEDURE, THE SUTURE BROKE. THE PT UNDERWENT A RE-OPERATION ON (B) (6) 2009. NO ADDITIONAL INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURGICAL STAINLESS STEEL SUTURE | SUTURE, NON-ABSORBABLE | GAQ | ETHICON, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |