MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2000-11-15 for BLAKEMORE TUBE 204860210 manufactured by Willy Rusch Ag.
[215838]
It was reported that the tube was sterilized prior to initial use. After sterilization it was noted that the numbers (depth measurements) had come off the tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610520-2000-00098 |
| MDR Report Key | 308688 |
| Report Source | 06 |
| Date Received | 2000-11-15 |
| Date of Report | 2000-11-13 |
| Date Mfgr Received | 2000-10-30 |
| Date Added to Maude | 2000-12-18 |
| 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 |
| Manufacturer Contact | ROLANDA SCOTT, DOCUMENT CONTROL |
| Manufacturer Street | 2450 MEADOWBROOK PARKWAY |
| Manufacturer City | DULUTH GA 30096 |
| Manufacturer Country | US |
| Manufacturer Postal | 30096 |
| Manufacturer Phone | 7706230816 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLAKEMORE TUBE |
| Generic Name | SENGSTAKEN TUBE |
| Product Code | FEF |
| Date Received | 2000-11-15 |
| Returned To Mfg | 2000-11-13 |
| Model Number | NA |
| Catalog Number | 204860210 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 298674 |
| Manufacturer | WILLY RUSCH AG |
| Manufacturer Address | WILLY RUSCH STRASSE 4-10 KERNEN GM 71394 |
| Baseline Brand Name | BLAKEMORE TUBE |
| Baseline Generic Name | SENGSTAKEN TUBE |
| Baseline Model No | NA |
| Baseline Catalog No | 204860210 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-11-15 |