MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2013-07-10 for ETHIBOND UNK manufactured by Ethicon Inc..
[3585433]
It was reported that a patient underwent a bilateral tibialis anterior tendon transfer on (b)(6) 2012 and suture was used. The patient returned to the operating room on (b)(6) 2013 for an incision and drainage and exision of bilateral plantar suture granulomas. The patient also cultured for staph aureus.
Patient Sequence No: 1, Text Type: D, B5
[10904888]
(b)(4). 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 | 2210968-2013-12796 |
| MDR Report Key | 3217669 |
| Report Source | 05,06,07 |
| Date Received | 2013-07-10 |
| Date of Report | 2013-06-24 |
| Date Mfgr Received | 2013-06-24 |
| Date Added to Maude | 2013-07-10 |
| 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 | 0 |
| Manufacturer Contact | KATHY RICE |
| Manufacturer Street | 4545 CREEK RD |
| Manufacturer City | CINCINNATI OH 452422803 |
| Manufacturer Country | US |
| Manufacturer Postal | 452422803 |
| Manufacturer Phone | 5133373299 |
| Manufacturer G1 | UNKNOWN |
| Manufacturer Street | UNKNOWN |
| Manufacturer City | X |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHIBOND |
| Generic Name | SUTURE NON ABSORBABLE |
| Product Code | GAS |
| Date Received | 2013-07-10 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| 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 | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876015 US 08876 0151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-07-10 |