MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-26 for CODMAN ME2 83-1367 manufactured by Codman & Shurtleff, Inc..
[107217354]
(b)(4). It has been reported that the device will be returned for evaluation. Upon completion of the investigation, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[107217355]
It was reported that there was there was small foreign material inside of the sterilization pack of the me2 device, and it was not possible to use it. The product was replaced with another one. No further information was provided by hospital. The product will be returned to your site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2018-10301 |
| MDR Report Key | 7465503 |
| Date Received | 2018-04-26 |
| Date of Report | 2018-04-09 |
| Date of Event | 2018-04-05 |
| Date Mfgr Received | 2018-07-02 |
| Device Manufacturer Date | 2017-03-23 |
| Date Added to Maude | 2018-04-26 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JAMES KENNEY |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088282726 |
| Manufacturer G1 | CODMAN & SHURTLEFF, INC. |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CODMAN ME2 |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY |
| Product Code | GCD |
| Date Received | 2018-04-26 |
| Returned To Mfg | 2018-05-01 |
| Catalog Number | 83-1367 |
| Lot Number | H60437 |
| Operator | PHYSICIAN |
| 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 | 2018-04-26 |