MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 1996-09-12 for AUTO SUTURE CHEMOSITE UNK manufactured by United States Surgical Corp..
[20867]
The device was implanted as an access port. Reportedly, seven months after it was implanted a crack was noticed in the catheter. The surgeon implanted a new port system. The hosp has reported that no pt injury occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219161-1996-00063 |
| MDR Report Key | 38452 |
| Report Source | 01,05,06,07 |
| Date Received | 1996-09-12 |
| Date of Report | 1996-09-12 |
| Date of Event | 1996-08-02 |
| Date Facility Aware | 1996-08-02 |
| Report Date | 1996-09-12 |
| Date Mfgr Received | 1996-08-13 |
| Date Added to Maude | 1996-09-19 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTO SUTURE CHEMOSITE |
| Generic Name | IMPLANTABLE ACCESS SYSTEM |
| Product Code | KJT |
| Date Received | 1996-09-12 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | M |
| Device Sequence No | 1 |
| Device Event Key | 39702 |
| Manufacturer | UNITED STATES SURGICAL CORP. |
| Manufacturer Address | 150 GLOVER AVE NORWALK CT 06856 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-09-12 |