MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-06-02 for HAKIM VENTRICULAR & PERITONEAL CATHETERS WITH BACTISEAL 82-3072 manufactured by Codman & Shurtleff, Inc..
[2003072]
Shunt infection is determined.
Patient Sequence No: 1, Text Type: D, B5
[9026149]
It has been communicated that the device and/or lot information is not available for evaluation. Without the device and/or lot information it is not possible for codman to conduct a proper investigation. If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a f/u report will be filed. Trends will be monitored for this and similar complaints. At the present time this complaint is considered closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2011-00199 |
| MDR Report Key | 2113777 |
| Report Source | 99 |
| Date Received | 2011-06-02 |
| Date of Event | 2011-03-10 |
| Date Mfgr Received | 2011-05-05 |
| Date Added to Maude | 2011-06-08 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283106 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HAKIM VENTRICULAR & PERITONEAL CATHETERS WITH BACTISEAL |
| Generic Name | SHUNT, CENTRAL NERVOUS & COMPS |
| Product Code | HCA |
| Date Received | 2011-06-02 |
| Model Number | NA |
| Catalog Number | 82-3072 |
| Lot Number | UNK |
| ID Number | NA |
| 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 MEDOS S.A. LE LOCLE CH-2400 SZ CH-2400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-06-02 |