MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,08 report with the FDA on 2015-02-17 for CODMAN 170412 manufactured by Surgical Specialties Puerto Rico Inc..
[5358675]
"the blade broke during use. Patient was not harmed. " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12843793]
The actual product involved with the incident reported is not available at this time. No inventory available for the finished good lot number reported or finished good product manufactured with the same blade component lot used to manufacture the lot reported. Method - the actual device is not available at this time. A biohazard kit was sent to customer for the return of the device. Results/conclusion - the actual device is not available at this time. Per an electric communication from customer, it was not possible to identify the specific lot. However, four suspects lots were provided; m655620, m655630, m655640, and m655650. Relevant portions of the device history records were reviewed. Finished good products were received into inventor without quality issues. The product from these finished good lots and all the components met surgical specialities puerto rico inc. Requirements throughout the incoming, manufacturing and the final inspection processes. No inventory available for the finished good lot reported nor product manufactured with the same blade component lot.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008845715-2015-00012 |
| MDR Report Key | 4536807 |
| Report Source | 00,08 |
| Date Received | 2015-02-17 |
| Date of Report | 2015-02-12 |
| Date of Event | 2014-11-19 |
| Date Mfgr Received | 2015-01-28 |
| Date Added to Maude | 2015-03-20 |
| 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 | MARCIA CARO, SR. QA. MGR. |
| Manufacturer Street | ROAD 459 KM 0.6 MONTANA INDUSTRIAL PARK |
| Manufacturer City | AGUADILLA PR 006030000 |
| Manufacturer Country | US |
| Manufacturer Postal | 006030000 |
| Manufacturer Phone | 7876581800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CODMAN |
| Generic Name | ULTRA MICRO KNIFE BLADE EA |
| Product Code | EMF |
| Date Received | 2015-02-17 |
| Model Number | 170412 |
| Catalog Number | 170412 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURGICAL SPECIALTIES PUERTO RICO INC. |
| Manufacturer Address | AGUADILLA PR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-17 |