FDA Adverse Event
Injury
Summary report: N
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
MDR report key: 1001095
·
Received February 22, 2008
Report
- Report Number
- 2210968-2008-00106
- Event Type
- Injury
- Date Received
- February 22, 2008
- Date of Event
- January 23, 2008
- Report Date
- January 25, 2008
- Manufacturer
- ETHICON, INC.
- Product Code
- GAS
- PMA / PMN Number
- N17804
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. THE ACTUAL DEVICE ASSOCIATED WITH THIS EVENT IS NOT KNOWN. INTL AFFILIATE REPORTS THE FOLLOWING POSSIBLE PRODUCTS: CODE X412H, LOT XPE905, MFG: 12/01/2006, EXP: 07/31/2011. CODE X425H, LOT UNK.
Description of Event or Problem · 1
INTERNATIONAL CUSTOMER REPORTS THAT A PT PRESENTED WITH A RECURRENT HERNIA THREE TO FIVE DAYS AFTER THE INITIAL SURGERY. THE PT WAS RETUNED TO SURGERY FOR REPAIR. CUSTOMER REPORTS THE SUTURES BROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETHIBOND EXTRA & EXCEL POLYESTER SUTURE | SUTURE, NON-ABSORBABLE | GAS | ETHICON, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK YR | Required Intervention |