MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-02-04 for NEOWRAP NC100-10 manufactured by Fisher & Paykel Healthcare, Ltd..
[1061775]
A hospital reported that the nc100 neowrap plastic film baby wraps were fused together. "patient care was compromised because of this defect. " further inquiries by the manufacturer revealed that the hospital had experienced this on 2 other patients previously, but were unable to provide further information.
Patient Sequence No: 1, Text Type: D, B5
[8178132]
(b) (4). The device is class i. The original device was discarded by the hospital. A device from the same lot is en route to the manufacturer. A follow up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611451-2009-00037 |
| MDR Report Key | 1345116 |
| Report Source | 05,06 |
| Date Received | 2009-02-04 |
| Date of Report | 2009-01-05 |
| Date Mfgr Received | 2009-01-05 |
| Date Added to Maude | 2010-01-11 |
| 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 | GORDON RICHMAN |
| Manufacturer Street | 15365 BARRANCA PKWY |
| Manufacturer City | IRVINE CA 926182216 |
| Manufacturer Country | US |
| Manufacturer Postal | 926182216 |
| Manufacturer Phone | 4534000 |
| Manufacturer G1 | FISHER & PAYKEL HEALTHCARE, LTD. |
| Manufacturer Street | 15 MAURICE PAYKEL PLACE EAST TAMAKI |
| Manufacturer City | AUCKLAND |
| Manufacturer Country | NZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOWRAP |
| Product Code | KME |
| Date Received | 2009-02-04 |
| Model Number | NC100-10 |
| Catalog Number | NC100-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISHER & PAYKEL HEALTHCARE, LTD. |
| Manufacturer Address | AUCKLAND NZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-02-04 |