MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-08-02 for COTTLE MALLET, FLAT NYLON FACE RH1541 manufactured by Cardinal Health.
[671992]
Nylon flakes from mallet fell off into patient during the procedure. Additionally, they retrieved the tip and it was unclear whether any particles got in the surgical site, but they irrigated the site and didn't see anything. The patient was put on antibiotics afterward as a precaution.
Patient Sequence No: 1, Text Type: D, B5
[8129458]
One instrument received for evaluation. Upon inspection, it was noted that the plastic replaceable tip was worn. Also noted were scratches and signs of normal wear and tear. A device history review was conducted with no issues noted. It was determined that this device was manufactured in 1999. A historical complaint review was also conducted with no trend found for this type of complaint on this product code. During the device labeling review, it was determined that the labeling states, "note that an examination of all instruments is recommended prior to use in order to decrease the potential for patient injury". Although the exact cause of the damage cannot be determined. It is possible that the damage was due to excessive forces being applied.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423507-2007-00085 |
| MDR Report Key | 888481 |
| Report Source | 05 |
| Date Received | 2007-08-02 |
| Date of Report | 2007-08-01 |
| Date of Event | 2007-07-03 |
| Date Mfgr Received | 2007-07-03 |
| Device Manufacturer Date | 1999-01-01 |
| Date Added to Maude | 2007-10-29 |
| 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 | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN ROAD, BLDG KB |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475786412 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COTTLE MALLET, FLAT NYLON FACE |
| Generic Name | MALLET |
| Product Code | GFJ |
| Date Received | 2007-08-02 |
| Returned To Mfg | 2007-07-16 |
| Model Number | RH1541 |
| Catalog Number | RH1541 |
| Lot Number | H99 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 905383 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | MCGAW PARK IL 60085 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-02 |