MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-10-28 for INFUSAPORT UNKNOWN LPS-7513 manufactured by Strato Medical Corp..
[11997]
Port inserted 9/22/94, pt went home. Port worked for 1 month. On 10/20/94 pt returned to hosp, x-ray revealed part of port catheter had broken off. Pt to or for removal. Unable to retrieve broken catheter. Broken part retrieved from left subclavian vein under fluoroscopy next day. New port inserted without problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 17809 |
| MDR Report Key | 17809 |
| Date Received | 1994-10-28 |
| Date of Report | 1994-10-26 |
| Date of Event | 1994-10-20 |
| Date Facility Aware | 1994-10-20 |
| Report Date | 1994-10-26 |
| Date Reported to FDA | 1994-10-26 |
| Date Reported to Mfgr | 1994-10-21 |
| Date Added to Maude | 1994-11-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFUSAPORT |
| Product Code | LPT |
| Date Received | 1994-10-28 |
| Model Number | UNKNOWN |
| Catalog Number | LPS-7513 |
| Lot Number | 415105 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 MO |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 17725 |
| Manufacturer | STRATO MEDICAL CORP. |
| Manufacturer Address | BEVERLY MA 019151892 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1994-10-28 |