MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-04-23 for ETHIBOND EXTRA & EXCEL POLYESTER SUTURE manufactured by Ethicon, Inc.
[3270483]
It was reported that a patient underwent an open incisional hernia procedure on (b)(6) 2013 and suture was used to secure the gore dualmesh in place. One week post-operatively, the patient returned to surgery to have the surgical wound washed due to an abdominal wound infection. The patient was readmitted with a tia and cellulitis of the skin near the incision. On (b)(6) 2013, the patient was seen in the office with seroma drainage and wound separation with fibrinous exudate. On (b)(6) 2013, the patient underwent wound exploration and sharp debridement of extensive and deep fibrinous exudate including covering of the mesh. The patient is stable post-operative, and possibly will need to have the mesh explanted. Culture results are pending.
Patient Sequence No: 1, Text Type: D, B5
[10617986]
(b)(4). Conclusion: no conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2013-04310 |
| MDR Report Key | 3072881 |
| Report Source | 05,06 |
| Date Received | 2013-04-23 |
| Date of Report | 2013-04-05 |
| Date Mfgr Received | 2013-04-05 |
| Date Added to Maude | 2013-04-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MS. KATHY RICE |
| Manufacturer Street | 4545 CREEK ROAD MAIL LOCATION 120 |
| Manufacturer City | CINCINNATI OH 45242 |
| Manufacturer Country | US |
| Manufacturer Postal | 45242 |
| Manufacturer Phone | 5133373299 |
| Manufacturer G1 | NI |
| Manufacturer Street | NI NI |
| Manufacturer City | NI NI |
| Manufacturer Postal Code | NI |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHIBOND EXTRA & EXCEL POLYESTER SUTURE |
| Generic Name | SUTURE, NON-ABSORBABLE |
| Product Code | GAS |
| Date Received | 2013-04-23 |
| Model Number | NA |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON, INC |
| Manufacturer Address | ROUTE 22 WEST PO BOX 151 SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-04-23 |