MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2018-02-02 for IDRT, UNKNOWN XXX-IDRT manufactured by Integra Lifesciences Corp.
[98841606]
Investigation completed on jan 26, 2018. The failure is unconfirmed, as there was no product returned for this complaint. Therefore, failure analysis could not be performed. It is difficult to pinpoint the exact root cause of the infection. 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. This includes ensuring that sterile product gets to the customer. Based on the risk documentation review, 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
[98841607]
The journal of tissue engineering and regenerative medicine (2017) published? Restoring full-thickness defects with spray skin in conjunction with dermal regenerate template and split thickness skin grafting: a pilot study?. This is a case of a patient that developed pseudomonal colonization of the right lower extremity surgical site at post-operative on day seven. The patient was placed on a 5-day course of ciprofloxacin iv, and melgisorb ag ((b)(6) health care, (b)(6)) was placed on the affected areas. The melgisorb was removed and replaced every 24 h for 3 days. The site healed without complication and there was no evidence that the colonization caused any delay in the healing of the surgical site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121308-2018-00009 |
| MDR Report Key | 7235533 |
| Report Source | LITERATURE |
| Date Received | 2018-02-02 |
| Date of Report | 2018-01-08 |
| Date Mfgr Received | 2018-01-08 |
| Date Added to Maude | 2018-02-02 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. VIVIAN NELSON |
| 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 | IDRT, UNKNOWN |
| Generic Name | INTEGRA |
| Product Code | MDD |
| Date Received | 2018-02-02 |
| Catalog Number | XXX-IDRT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORP |
| Manufacturer Address | 311 ENTERPRISE DRIVE 311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-02 |