MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1999-02-19 for CAVERMAP, 8300, DISPOS. KIT CAVERMAP DISPOSABLES manufactured by Uromed Corp..
[130451]
While opening the disposable kit, the mylar sterile barrier had been torn by the distal end of the probe tip, compromising the sterility of the package.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1224675-1999-00059 |
| MDR Report Key | 211868 |
| Report Source | 07 |
| Date Received | 1999-02-19 |
| Date of Report | 1999-02-11 |
| Date of Event | 1999-02-09 |
| Date Mfgr Received | 1999-02-09 |
| Device Manufacturer Date | 1999-01-01 |
| Date Added to Maude | 1999-03-03 |
| 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 | 0 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1999-01-8300 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAVERMAP, 8300, DISPOS. KIT |
| Generic Name | DISPOSABLE KIT |
| Product Code | MNG |
| Date Received | 1999-02-19 |
| Returned To Mfg | 1999-02-10 |
| Model Number | CAVERMAP DISPOSABLES |
| Catalog Number | 8300 |
| Lot Number | JBH9014 |
| ID Number | DISPOSABLE KIT |
| Device Expiration Date | 1999-07-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 205612 |
| Manufacturer | UROMED CORP. |
| Manufacturer Address | 1400 PROVIDENCE HIGHWAY NORWOOD MA 02062 US |
| Baseline Brand Name | CAVERMAP, 8300, DISPOS. KIT |
| Baseline Generic Name | DISPOSABLE KIT |
| Baseline Model No | CAVERMAP DISPOS |
| Baseline Catalog No | 8300 |
| Baseline ID | DISPOSABLE KIT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-02-19 |