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 2016-02-01 for IDRT, UNKNOWN XXX-IDRT manufactured by Integra Lifesciences Corporation.
[37244550]
It was reported the product was delivered late. The customer ordered the material on (b)(4) 2016, at approximately 15:30. The product was supposed to be delivered on (b)(4) 2016 by 09:00. It finally arrived at 10:28. The patient was under anesthesia and in the or around 08:30. The patient needed to be prepared for the application of idrt since it was a burn patient with 95% burned surface. "the idrt was not needed until it arrived in the or, but still it was not delivered on time "this is a 1. 5 hour delay. " it was reported the delay did not harm the patient. No device failure is alleged. The product remains implanted in the patient.
Patient Sequence No: 1, Text Type: D, B5
[46619945]
Integra completed its internal investigation 7mar2016. The investigation included: conclusion: as the information related to the correct shipping time was only given by phone there is no proof of the correct transferred shipping time. The root cause for the delay on delivery could happen based on the not clear defined arrival time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2016-00001 |
| MDR Report Key | 5401359 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2016-02-01 |
| Date of Report | 2016-01-06 |
| Date of Event | 2016-01-06 |
| Date Mfgr Received | 2016-03-07 |
| Date Added to Maude | 2016-02-01 |
| 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 | 2016-02-01 |
| 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 | 2016-02-01 |