MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2011-11-04 for MCGIVNEY HEMO LIGATOR 7 28-150 manufactured by Integra, York - Imiltex.
[2363128]
On (b)(6) 2011, the nurse reported that the hemorrhoid ligator "fell apart at the start of a procedure while loading a rubber band" for a hemorrhoid ligation. There was no pt injury; the pt did not receive anesthesia. The pt received antibiotics and a bowel preparation prior to the procedure. The procedure was cancelled and will be rescheduled as the physician did not have a spare device to use to perform the procedure.
Patient Sequence No: 1, Text Type: D, B5
[9484847]
To date the device involved in the reported incident has not been received for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2011-00080 |
| MDR Report Key | 2338913 |
| Report Source | 05,08 |
| Date Received | 2011-11-04 |
| Date of Report | 2011-11-04 |
| Date of Event | 2011-09-12 |
| Date Mfgr Received | 2011-10-18 |
| Date Added to Maude | 2012-07-12 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CAREN FERNANDEZ |
| Manufacturer Street | 315 ENTERPRISE DR. |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MCGIVNEY HEMO LIGATOR 7 |
| Generic Name | M17 - RECTAL |
| Product Code | EXX |
| Date Received | 2011-11-04 |
| Catalog Number | 28-150 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA, YORK - IMILTEX |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-04 |