MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,05,07 report with the FDA on 2014-08-01 for IDRT, UNKNOWN XXX-IDRT manufactured by Integra Lifesciences Corp..
[4799198]
It was reported as part of a study conducted titled: (b)(4), subject received integra on (b)(6) 2011. The subject's wound, which was on the left lateral ankle, had a venous etiology. The wound's approx measurement was 3. 7cm length x 2. 8cm width. On (b)(6) 2011 the subject experienced an adverse event of "infection. " this event was documented as mild in severity and possibly related to the initial index treatment with integra. It was not considered a serious adverse event. The action taken was treatment with levaquin and doxycycline, dakins and dressing changes. On (b)(6) 2011 the subject was readmitted for an unspecified time for treatment with iv antibiotics, which increased the severity of the event to severe. Then on (b)(6) 2011 subject again received prescription doxycycline for the infection. At this time the event was considered mild in severity, but still possibly related to integra. The infection resolved (b)(6) 2011. The wound was deemed healed (b)(6) 2011, but recurred (b)(6) 2012.
Patient Sequence No: 1, Text Type: D, B5
[11990517]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2014-00033 |
| MDR Report Key | 4029784 |
| Report Source | 02,05,07 |
| Date Received | 2014-08-01 |
| Date of Report | 2014-07-16 |
| Date of Event | 2011-02-22 |
| Date Mfgr Received | 2014-07-16 |
| Date Added to Maude | 2014-09-03 |
| 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 | CAREN FINKELSTEIN |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IDRT, UNKNOWN |
| Generic Name | INTEGRA |
| Product Code | MDD |
| Date Received | 2014-08-01 |
| Catalog Number | XXX-IDRT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORP. |
| Manufacturer Address | PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2014-08-01 |