MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-02-27 for RANEY SCALP CLIPS 20-1037 manufactured by Codman & Shurtleff, Inc..
[68426591]
Udi: (b)(4). Upon completion of the investigation a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[68426592]
As reported by the ous affiliate, during cranial surgery, when a raney scalp clip 10 pack was opened there were 11 in the pack. An alternate pack was used; no delays or adverse events recorded.
Patient Sequence No: 1, Text Type: D, B5
[73355716]
The device has been returned. Upon completion of the investigation, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[73693199]
Two inner packaging pouches and eleven loose clips were returned for evaluation. While we are unable to definitively confirm that the eleven clips came from a single package, we are confirming the complaint based on the information reported. A review of manufacturing records found no issues related to piece counts. There are several piece count checks in place for this product throughout the processes-the auto bagger deflects rejects according to piece counts and a second scale is to be used to verify 10 counts. Trends will be monitored for this or similar complaints. At present, we consider this complaint to be closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2017-10126 |
| MDR Report Key | 6361518 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-02-27 |
| Date of Event | 2013-11-21 |
| Date Mfgr Received | 2017-03-21 |
| Date Added to Maude | 2017-02-27 |
| 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 | 2017-02-27 |
| Returned To Mfg | 2017-02-28 |
| Catalog Number | 20-1037 |
| Lot Number | EJ601 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-02-27 |