MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2010-01-20 for CODMAN BACTISEAL CATHETER KIT 82-3072 manufactured by Codman & Shurtleff, Inc..
[20164760]
Affiliate reported that the pt developed an infection. The pt was treated with antibiotics and recovered nicely. Approx 6 months later, the pt developed another infection and the decision was made to explant the device and treat the pt with antibiotics. The pt has fully recovered.
Patient Sequence No: 1, Text Type: D, B5
[20610502]
Upon completion of the investigation, a follow up will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2010-00020 |
| MDR Report Key | 1583497 |
| Report Source | 01,07 |
| Date Received | 2010-01-20 |
| Date of Event | 2009-12-13 |
| Date Mfgr Received | 2009-12-26 |
| Date Added to Maude | 2010-01-26 |
| 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. |
| Manufacturer Street | RUE GIRARDET 29 MEDOS S.A. |
| 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 | CODMAN BACTISEAL CATHETER KIT |
| Generic Name | HAKIM VENTRICULAR & PERITONEAL CATHETERS WITH BACTISEAL |
| Product Code | HCA |
| Date Received | 2010-01-20 |
| Model Number | NA |
| Catalog Number | 82-3072 |
| Lot Number | UNK |
| 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. |
| Manufacturer Address | RUE GIRARDET 29 MEDOS S.A. LE LOCLE CH-2400 SZ CH-2400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 82 | 1. Required No Informationntervention | 2010-01-20 |