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 2017-11-27 for RANEY SCALP CLIPS 20-1037 manufactured by Codman & Shurtleff, Inc..
[93581659]
(b)(4). For p/c 801400- patties:samples were not returned therefore evaluation to confirm miscount could not be completed. A dhr review was completed and no errors were found. Manufacturing documentation was reviewed for any variations in current process and no variations were found. Lot number was sent in with the sample (lot number ha8252) for p/c 201037 raney clips: the manufacturer was notified of the complaint of "miscount". The product was not returned; therefore, the reported " raney clip miscount" could not be verified. Dhr review for both lots reported ak605 and dk653, there were no manufacturing defects noted during the manufacturing process. We will continue to monitor for this or similar complaints for these product codes. At this time tis complaint is considered to be closed. Device not available.
Patient Sequence No: 1, Text Type: N, H10
[93581660]
As reported by the ous affiliate, a package of codman patties 10-pack contained 11patties, a codman rainey clip 10-pack contained 21 clips and another codman rainey clip 10-pack contained 11 clips. Once count was done, hospital discarded extra products in packages and continued procedure. There were no reports of delay or patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2017-10884 |
| MDR Report Key | 7060063 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-27 |
| Date of Event | 2017-11-06 |
| Date Mfgr Received | 2018-02-16 |
| Date Added to Maude | 2017-11-27 |
| 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 | 2017-11-27 |
| Returned To Mfg | 2018-01-16 |
| Catalog Number | 20-1037 |
| Lot Number | AK605 |
| 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 | 2017-11-27 |