MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2004-10-29 for VS-100 STANDARD VIDEO SIGMOIDOSCOPE 30500 manufactured by Welch Allyn, Inc..
[312504]
Pt underwent an endoscopic procedure using sigmoidoscope. Post-procedure, the pt complained of severe abdominal pain. The pt was hospitalized. The dr believes that the pt may have suffered from a glutaraldehyde burn in the lower bowel.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1316463-2004-00012 |
MDR Report Key | 552595 |
Report Source | 06 |
Date Received | 2004-10-29 |
Date of Report | 2004-10-29 |
Date of Event | 2003-02-13 |
Date Mfgr Received | 2003-02-13 |
Date Added to Maude | 2004-11-02 |
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 | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 0 |
Manufacturer Contact | CHRISTOPHER KLACZYK |
Manufacturer Street | 4341 STATE STREET RD P.O. BOX 220 |
Manufacturer City | SKANEATELES FALLS NY 131530220 |
Manufacturer Country | US |
Manufacturer Postal | 131530220 |
Manufacturer Phone | 3156853694 |
Manufacturer G1 | * |
Manufacturer Street | * |
Manufacturer City | * |
Manufacturer Country | * |
Single Use | 3 |
Previous Use Code | 3 |
Removal Correction Number | NA |
Event Type | 3 |
Type of Report | 3 |
Brand Name | VS-100 STANDARD VIDEO SIGMOIDOSCOPE |
Generic Name | SIGMOIDOSCOPE |
Product Code | FAM |
Date Received | 2004-10-29 |
Returned To Mfg | 2003-03-20 |
Model Number | VS-100 |
Catalog Number | 30500 |
Lot Number | 3051950 |
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 | 542147 |
Manufacturer | WELCH ALLYN, INC. |
Manufacturer Address | 4341 STATE ST. RD. P.O. BOX 220 SKANEATELES FALLS NY 131530220 US |
Baseline Brand Name | VS-100 STANDARD VIDEO SIGMOIDOSCOPE |
Baseline Generic Name | SIGMOIDOSCOPE |
Baseline Model No | VS-100 |
Baseline Catalog No | 30500 |
Baseline ID | NA |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization | 2004-10-29 |