MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-07-10 for ETHIBOND UNK manufactured by Ethicon Inc..
[18306829]
It was reported that a patient underwent a right achilles tendon lengthening procedure on (b)(6) 2012 and suture was used. The patient developed a possible infection and was returned to surgery on (b)(6) 2013 for an incision and drainage. A deep culture was taken. The culture was negative, however, the patient had already been treated with antibiotics.
Patient Sequence No: 1, Text Type: D, B5
[18403635]
(b)(4) - infection occurred. 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 | 2210968-2013-12727 |
| MDR Report Key | 3216552 |
| Report Source | 05,07 |
| 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 |