MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-12-13 for OMNIGRAFT, UNKNOWN XXX-OMNIGRAFT manufactured by Integra Lifesciences Corporation.
[94668034]
Investigation completed 08dec2017. No product was returned for this complaint. Therefore, failure analysis could not be performed. The omnigraft product was used during surgery. No product lot number is provided so a dhr review could not be conducted. All product is released based on passing of all in process and finished goods criteria. Due to lack of product id and lot number for this complaint, another query was performed of integra's complaints database for the timeframe of 12 months (from 17 november 2016 to present (~29 november 2017)) using the keywords? Infection? ,? Pus,? ? Green? ,? Omnigraft? , or? Omnigraft-infection.? Only the current complaint was found based on the query. The calculated complaint rate is 0. 152%. It is difficult to pinpoint the exact root cause of the infection. The most probable root cause can be that the environment post application was inadequate for wound healing.
Patient Sequence No: 1, Text Type: N, H10
[94668035]
It was reported that a patient presented to the clinic on (b)(6) 2017 with green pus under the integra silicone in his hand. The treating physician at the clinic acknowledged he was treating an infection and wanted to know what topical antibiotics could be used with the graft; if it was possible to save the graft. He reported he was not very familiar with integra or omnigraft. He was unable to visibly detect any meshing. Another physician initially treated the patient for a traumatic injury of the left hand. Approximately 2 to 3 months ago, the patient had the first application of integra placed for a wound that had an exposed tendon. The patient had a second piece of integra placed approximately 8 days ago from the reporting date of (b)(6) 2017. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121308-2017-00012 |
| MDR Report Key | 7112486 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-12-13 |
| Date of Report | 2017-11-17 |
| Date of Event | 2017-11-17 |
| Date Mfgr Received | 2017-11-17 |
| Date Added to Maude | 2017-12-13 |
| 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 | DENTAL HYGIENIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER ROWENA BUNUAN |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Street | 105 MORGAN LANE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08536 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNIGRAFT, UNKNOWN |
| Generic Name | INTEGRA OMNIGRAFT DERMAL REGENERATION MATRIX |
| Product Code | MDD |
| Date Received | 2017-12-13 |
| Catalog Number | XXX-OMNIGRAFT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | 105 MORGAN LANE 105 MORGAN LANE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-13 |