MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-02-16 for 36KHZ CEM NOSECONE STERILE * C6636 manufactured by Integra Lifesciences Corporation.
[587105]
User facility expected overnight early morning delivery of the device needed for an am surgery. The product was not rec'd in time for the procedure. It has been reported that the pt was on the operating table and the surgery was subsequently cancelled since the device did not arrive. Availability of early morning overnight delivery was confirmed by the carrier prior to scheduling the shipment. This info was provided incorrectly, and the device was shipped for regular overnight receipt.
Patient Sequence No: 1, Text Type: D, B5
[7939883]
No product return is expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003418325-2007-00001 |
| MDR Report Key | 822714 |
| Report Source | 06 |
| Date Received | 2007-02-16 |
| Date of Report | 2007-02-15 |
| Date of Event | 2007-01-18 |
| Date Mfgr Received | 2007-01-18 |
| Date Added to Maude | 2007-03-05 |
| 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 | 0 |
| Manufacturer Contact | LINDA GOODSTEIN |
| Manufacturer Street | 311 ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362269 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORP |
| Manufacturer Street | 311 ENTERPRISE DR |
| Manufacturer City | PLAINSOBORO 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 | 36KHZ CEM NOSECONE STERILE |
| Generic Name | * |
| Product Code | EPP |
| Date Received | 2007-02-16 |
| Model Number | * |
| Catalog Number | C6636 |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 810116 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | * PLAINSBORO NJ * US |
| Baseline Brand Name | 36KHZ CEM NOSECONE STERILE |
| Baseline Generic Name | * |
| Baseline Model No | * |
| Baseline Catalog No | C6636 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-02-16 |