MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2011-01-31 for HAKIM VENTRICULAR CATHETER W/BACTISEAL, STYLET, AND RA ADAPTOR 82-3074 manufactured by Codman & Shurtleff, Inc. Medos S.a..
[17069878]
Affiliate reported that the device was revised due to inflammatory symptoms. The valve remained in place. A culture sample was taken and the peritoneal catheter was positive for ralstonia pickettii. The ventricular catheter was negative and csf was also negative. They think that the contamination must have occurred during the operation in (b)(6). In (b)(6), the pt developed symptoms of abdominal obstruction and they have to do a laparotomy. Infection was still present around the peritoneal catheter.
Patient Sequence No: 1, Text Type: D, B5
[17183113]
Upon completion of the investigation, a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2011-00029 |
| MDR Report Key | 1977706 |
| Report Source | 01,07 |
| Date Received | 2011-01-31 |
| Date Mfgr Received | 2011-01-05 |
| Date Added to Maude | 2011-02-07 |
| 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 | MATTHEW 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. MEDOS S.A. |
| 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 CATHETER W/BACTISEAL, STYLET, AND RA ADAPTOR |
| Generic Name | SHUNT, CENTRAL NERVOUS SYSTEM & COMPS |
| Product Code | HCA |
| Date Received | 2011-01-31 |
| Model Number | NA |
| Catalog Number | 82-3074 |
| Lot Number | CLFC7W |
| 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 | 2011-01-31 |