MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-07-07 for SILASTIC MALECOT CATHETER 322-24 manufactured by Dow Corning Corp..
[108944]
On 3/10/98, md attempted to remove suprapubic malecot catheter. This was placed in o. R. On 2/14/98. Tip of catheter broke off internally. Retained section was surgically removed during exploration on 3/10/98. The pt appears to have had a wound infection post-operative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1816403-1998-00308 |
| MDR Report Key | 176245 |
| Report Source | 06 |
| Date Received | 1998-07-07 |
| Date of Report | 1998-03-18 |
| Date of Event | 1998-03-10 |
| Date Facility Aware | 1998-03-10 |
| Report Date | 1998-03-18 |
| Date Reported to FDA | 1998-03-20 |
| Date Reported to Mfgr | 1998-03-20 |
| Date Mfgr Received | 1998-06-10 |
| Date Added to Maude | 1998-07-13 |
| 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 | SILASTIC MALECOT CATHETER |
| Generic Name | MALECOT CATHETER |
| Product Code | FEW |
| Date Received | 1998-07-07 |
| Model Number | NA |
| Catalog Number | 322-24 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 155167 |
| Manufacturer | DOW CORNING CORP. |
| Manufacturer Address | 2200 WEST SALZBURG RD AUBURN MI 48611 US |
| Baseline Brand Name | SILASTIC MALECOT CATHETER |
| Baseline Generic Name | MALECOT CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | 322-24 |
| Baseline ID | NA |
| Baseline Device Family | DRAIN, MALECOT |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-07-07 |