MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-11-24 for RANEY SCALP CLIPS 20-1037 manufactured by Codman & Shurtleff, Inc..
[31992612]
Upon completion of the investigation a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[31992613]
A hair was found in the sterile package. Event occurred prior to surgery, no delays, no adverse consequences; surgeon didn't open package, sent it to purchasing. On (b)(6) 2015 per rep, reported contamination inside sterile barrier.
Patient Sequence No: 1, Text Type: D, B5
[36621447]
It was initially reported that the device would be returned for evaluation. Multiple attempts to obtain the sample were unsuccessful. This report has been updated to reflect the corrected information. Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed. A review of manufacturing records was performed by the supplier and no nonconformances were noted. The cause(s) of the difficulty reported by the customer could not be determined. If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed. At present, we consider this complaint to be closed. Trends will be monitored for this or similar complaints. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2015-10700 |
| MDR Report Key | 5245645 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-11-24 |
| Date of Event | 2015-11-05 |
| Date Mfgr Received | 2016-01-19 |
| Date Added to Maude | 2015-11-24 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR JAMES KENNEY |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088282726 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RANEY SCALP CLIPS |
| Generic Name | CLIPS, SCALP |
| Product Code | HBO |
| Date Received | 2015-11-24 |
| Catalog Number | 20-1037 |
| Lot Number | BH607 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-24 |