MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-12-30 for HAKIM VENTRICULAR, W/BACTISEAL, STYLET AND RA ADAPTOR 82-3074 manufactured by Codman & Shurtleff, Inc., Medos S.a..
[20918630]
Customer reported that pt received a valve with bactiseal and returned to the hospital less than two weeks later with meningitis. While removing the catheter, the device was met with resistance and broke leaving a piece of the catheter in the abdomen. The broken piece was eventually retrieved. Although the pathology reports are not available. It was explained that the pt csf was tested and although the results could not quantify staff, it did appear that the pt had a sensitivity to staff, but when the culture was grown staff was not present.
Patient Sequence No: 1, Text Type: D, B5
[21146222]
Upon completion of the investigation, a f/u report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2011-00056 |
| MDR Report Key | 2001418 |
| Report Source | 05 |
| Date Received | 2010-12-30 |
| Date Mfgr Received | 2011-01-19 |
| Date Added to Maude | 2011-03-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MATHEW KING |
| Manufacturer Street | 325 PARAMOUNT DR. |
| 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, W/BACTISEAL, STYLET AND RA ADAPTOR |
| Generic Name | SHUNT, CENTRAL NERVOUS SYSTEM & COMPS |
| Product Code | HCA |
| Date Received | 2010-12-30 |
| Model Number | NA |
| Catalog Number | 82-3074 |
| Lot Number | CLMDM7 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN & SHURTLEFF, INC., MEDOS S.A. |
| Manufacturer Address | RUE GIRARDET 29 LE LOCLE CH-2400 SZ CH-2400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-12-30 |