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 |