MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-09 for GENT-L-KARE 107037 manufactured by Medegen Medical Products.
[144938927]
Pt came to gi lab for flexible sigmoidoscopy. When procedure started and scope inserted, a cap from an enema was found approx 2 inches into rectum. Pt sustained mucosal ulceration from the cap of an enema. We understand this was user error as enema cap was not removed before enema given. Although, we felt this was a reportable event as the tubing and enema cap are the same color - blue. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086537 |
| MDR Report Key | 8600384 |
| Date Received | 2019-05-09 |
| Date of Report | 2019-05-06 |
| Date of Event | 2019-03-20 |
| Date Added to Maude | 2019-05-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | GENT-L-KARE |
| Generic Name | ENEMA KIT |
| Product Code | FCE |
| Date Received | 2019-05-09 |
| Model Number | 107037 |
| Lot Number | 1060371024 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDEGEN MEDICAL PRODUCTS |
| Manufacturer Address | GALLAWAY TN 38036 US 38036 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-09 |