MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-25 for GROMCO manufactured by Allied Healthcare Products, Inc..
[112218580]
Male infant undergoing circumcision with gromco 1. 1 cm clamp. According to the physician, the device did not appear to crimp down enough to "seal" foreskin, causing more bleeding than normal. Additional pressure to the site and monitoring to ensure hemostasis. Infant did not have a prolonged stay and was discharged without complication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7634160 |
| MDR Report Key | 7634160 |
| Date Received | 2018-06-25 |
| Date of Report | 2018-05-29 |
| Date of Event | 2018-05-26 |
| Report Date | 2018-05-29 |
| Date Reported to FDA | 2018-05-29 |
| Date Reported to Mfgr | 2018-06-25 |
| Date Added to Maude | 2018-06-25 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| 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 | 3 |
| Brand Name | GROMCO |
| Generic Name | CLAMP, CIRCUMCISION |
| Product Code | HFX |
| Date Received | 2018-06-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLIED HEALTHCARE PRODUCTS, INC. |
| Manufacturer Address | 1720 SUBLETTE AVE. SAINT LOUIS MO 63110 US 63110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-25 |