MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-10-22 for ETHIBOND EXTRA & EXCEL POLYESTER SUTURE manufactured by Ethicon, Inc..
[16584904]
It was reported by the patient that she underwent an abdominal wall plication surgery in (b)(6) 2004 and suture was used. In about (b)(6) 2012, she noted a small opening in the middle of the incision with discharge. The opening grew to the size of a quarter with clear sometimes puss like discharge. The wound continues to be quarter size with drainage. The patient has been treated with antibiotics. No cultures have been performed. The primary physician has recommended that the suture be removed. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[16602867]
(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 | 2210968-2012-06694 |
| MDR Report Key | 2799314 |
| Report Source | 04 |
| Date Received | 2012-10-22 |
| Date of Report | 2012-09-26 |
| Date Mfgr Received | 2012-09-26 |
| Date Added to Maude | 2012-10-22 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MR. DANIEL LAMONT |
| Manufacturer Street | ROUTE 22 WEST PO BOX 151 |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082182708 |
| 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 | 2012-10-22 |
| 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 | 2012-10-22 |