MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-11 for MURANAKA SURGICAL MARKING PEN, STERILE MMI02730PBX manufactured by Aspen Surgical Products, Caledonia.
[119943940]
Aspen surgical received a report from the distributor indicating that a surgical marking pen was discovered with a sealing defect. The item was not in use. No injury/death was reported. A photo and lot number were provided for review. Analysis of the finished good lot number was reviewed. No non-conformance's for this issue were noted during the manufacturing process. No sample was returned for evaluation, therefore no further information is available on the product at this time. If a sample becomes available and any additional relevant information is identified following completion of the evaluation, the additional relevant information will be submitted in a supplemental report. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[119943941]
Aspen surgical received a report from the distributor indicating that a surgical marking pen was discovered with a sealing defect. The item was not in use. No injury/death was reported. This report was filed in our complaint handling system as number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1836161-2018-00096 |
| MDR Report Key | 7864497 |
| Date Received | 2018-09-11 |
| Date of Report | 2018-08-14 |
| Date of Event | 2018-05-23 |
| Date Mfgr Received | 2018-08-14 |
| Device Manufacturer Date | 2018-01-31 |
| Date Added to Maude | 2018-09-11 |
| 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 | MR. JORDAN HACKERT |
| Manufacturer Street | 6945 SOUTHBELT DR. S.E. |
| Manufacturer City | CALEDONIA MI 49316 |
| Manufacturer Country | US |
| Manufacturer Postal | 49316 |
| Manufacturer Phone | 6165367508 |
| Manufacturer G1 | SAME AS ABOVE |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MURANAKA SURGICAL MARKING PEN, STERILE |
| Generic Name | MARKING PEN |
| Product Code | FZZ |
| Date Received | 2018-09-11 |
| Model Number | MMI02730PBX |
| Lot Number | 156085 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASPEN SURGICAL PRODUCTS, CALEDONIA |
| Manufacturer Address | 6945 SOUTHBELT DR. S.E. CALEDONIA MI 49316 US 49316 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-11 |