MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2016-02-23 for IDRT, UNKNOWN XXX-IDRT manufactured by Integra Lifesciences Corporation.
[38791807]
It was reported the date of the event is (b)(6) 2016, the product had been implanted for 10 days. It was reported there was a "strong infection / supply loss of the product 99%, hematoma formation and massive secretion volume, so the product had to be completely removed. " i was reported the customer/surgeon usually do not have bigger infections. There was no infection before the product was applied. The patient was given antibiotics after a "antibiogramm" and a smear. There was a large amount of exposed scull and 2 sheets of product were used. It was also reported: patient injury / death alleged? No. Device in contact with patient? Yes. Delay in surgery due to product problem? No. How long? 10 minutes. Is product being returned? No.
Patient Sequence No: 1, Text Type: D, B5
[41360239]
Additional information received 22feb2016. It was confirmed the device was taken off and thrown (away) due to infection. Culture results were requested. The request was denied,?? Because of data protection from the hospital.? It was reported,? (the) patient is out of the hospital after the second treatment with idrt, so far there is no infection and looks good. Antibiotics were given after the failure and before the second use of idrt.? Consequences for the patient, in this case, were the longer stay in the hospital, no effect to the patient. It was reported the hospital did not definitively identify the cause of the infection. Integra completed its internal investigation 13mar2016. The investigation included: method: review of device history records. Review of complaint management database for similar complaints. Results: no product lot number was provided with this complaint; therefore, dhr review cannot be performed. While a specific lot nc query could not be performed for this complaint, any deviations that occur are investigated upon discovery and product impact assessment and risk assessment are determined for any associated lots under the deviations. A query was performed. No results were found. Conclusion: in complaint description and attached pictures, it is evident that the treatment area was 10x12. 5 cm. Two pieces of idrt-ts were used on the area. Susceptibility testing was performed on the infection, which could help identify the cause/source of the infection. However, due to the hospital? S data protection policy, the result was not shared with integra for this investigation. While the susceptibility result was not shared, the customer did share that the cause of the infection could not be identified during their investigation. The causes of infection identified in the mdha include nonsterile device implanted in patient, expired device implanted in patient, inadequate post-operative care, inadequate
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2016-00004 |
| MDR Report Key | 5453947 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2016-02-23 |
| Date of Report | 2016-01-28 |
| Date of Event | 2016-01-28 |
| Date Mfgr Received | 2016-02-22 |
| Date Added to Maude | 2016-02-23 |
| 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 | USER MARIA LEONARD |
| 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 | MGR |
| Date Received | 2016-02-23 |
| Catalog Number | XXX-IDRT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Required No Informationntervention | 2016-02-23 |