MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-11-12 for IDRT-TS 8X10 SINGLE DOMESTIC 38101 manufactured by Integra Lifesciences Corporation.
[126886468]
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
[126886509]
1 of 2 reports - other mfg report number: 1121308-2018-00096. It was reported that the patient had idrt applied to bilateral feet due to a burn injury on (b)(6) 2018. The left foot eventually got infected with pseudomonas and the product was removed on (b)(6) 2018. Patient got sepsis and passed away. The specific date of death was not provided, only that was on the week of (b)(6). The doctor believes that there was further burn conversion post application which contributed to the infection.
Patient Sequence No: 1, Text Type: D, B5
[129800739]
There were two issues reported within the complaint: right foot: product did not take and never adhered and was pussed out. Left foot: resulted in pseudomonas. Per additional information provided, patient was not in good health and was on dialysis. For both cases, it is difficult to pinpoint the exact root cause. Per dhr review, all products were released based on passing of all in process and finished goods criteria. This includes ensuring that sterile product gets to the customer. There is no indication that the production process may have contributed to this complaint. All test results passed the procedural specifications, and there were no defects observed in sterility of product that can lead to infection on one foot and? Failure to take? On another foot. The failure is unconfirmed, as there was no product returned for this complaint; it was used during surgery. Therefore, failure analysis could not be performed. Based on the risk documentation review, the most probable root cause can be that the environment post application was inadequate for wound healing for both cases. In addition, the patient was not in good health (dialysis) during application of product on both right foot and left foot so other health issues could also have resulted in infection (pseudomonas) on left foot post application and failure of product to take on right foot.
Patient Sequence No: 1, Text Type: N, H10
[129800740]
Patient Sequence No: 1, Text Type: D, B5
[130219545]
Additional information received from the doctor on 06-dec-2018, stating the patient had a full thickness scalding burn on both feet, extended to mid-calf with a total surface body area of 5%. No other products were concurrently used on the patient.
Patient Sequence No: 1, Text Type: N, H10
[130219546]
N/a.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121308-2018-00095 |
| MDR Report Key | 8060864 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-11-12 |
| Date of Report | 2018-10-15 |
| Date Mfgr Received | 2018-12-06 |
| Date Added to Maude | 2018-11-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER 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-TS 8X10 SINGLE DOMESTIC |
| Generic Name | IDRT-TS |
| Product Code | MDD |
| Date Received | 2018-11-12 |
| Catalog Number | 38101 |
| Lot Number | 2282097 |
| 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 CORPORATION |
| Manufacturer Address | 105 MORGAN LANE 105 MORGAN LANE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-11-12 |