MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-08 for NI UNK HAKIM manufactured by Codman & Shurtleff, Inc..
[132486584]
Udi -- unknown part number, attempts are being made to obtain, currently the udi is unavailable. It has been reported that the device will be returned for evaluation. Upon receipt of the device or additional relevant information, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[132486585]
It was reported from biomarin, that a patient had an implantation of an intracerebral rickham ventriculostomy (icv) set (codman shurtleff generic icv device). The lot number and model number were not reported. On an unspecified dated, magnetic resonance imaging confirmed that the device was placed in the wrong position. The patient had a revision surgery to correct the placement of the icv device. The outcome of the event was reported as recovering/resolving. The reporter assessed the event of device deployment issue as not related to treatment with bmn 190. Other etiological factors included wrong placement of the catheter. Additional information has been requested and, if received, the report will be updated. This is the first of 2 devices being registered; the other device is registered as (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2019-10022 |
| MDR Report Key | 8228386 |
| Date Received | 2019-01-08 |
| Date of Report | 2018-12-20 |
| Date of Event | 2018-12-10 |
| Date Mfgr Received | 2019-01-14 |
| Date Added to Maude | 2019-01-08 |
| 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 | KAREN ANIGBO |
| Manufacturer Street | 11 CABOT BOULEVARD |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 7819715608 |
| Manufacturer G1 | CODMAN & SHURTLEFF, INC. |
| Manufacturer Street | RUE GIRARDET 29 |
| Manufacturer City | LE LOCLE CH 2400 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH 2400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NI |
| Generic Name | NI |
| Product Code | HCA |
| Date Received | 2019-01-08 |
| Catalog Number | UNK HAKIM |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | RUE GIRARDET 29 LE LOCLE CH 2400 SZ CH 2400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-08 |