MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-09 for ACCU-LINE P-1RLNS manufactured by Accu-line Products Inc..
[144600104]
Avid medical is the manufacturer of a custom procedure tray ref: stva014-04, custom knee arthroscopy, that includes the following component: marker, skin ruler & 6 labels, vendor part # p-1rlns manufactured by accu-line products inc. Avid medical received a complaint on 04/19/19 originated by phil moran, deputy facility chief supply chain officer, of st. Cloud va health care system. The complaint states that during a knee arthroscopy procedure, the medical team observed on the monitor screen purple "floaters" or flakes believed to be from the skin marker in direct contact with the surgical wound. The surgeon uses the skin marker to indicate the incision line. The complaint component was not available for further evaluation. Avid medical issued formal complaint # (b)(4) to the manufacturer accu-line products inc concerning the flaking of the skin marker for item# p-1rlns, mfg lot# 80109. However, avid medical discovered the site has since went out of business. No patient injury was reported. The medical team stated that "we irrigated the wound thoroughly. ".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1047429-2019-00007 |
| MDR Report Key | 8595227 |
| Report Source | USER FACILITY |
| Date Received | 2019-05-09 |
| Date of Report | 2019-05-09 |
| Date of Event | 2019-04-12 |
| Date Mfgr Received | 2019-04-19 |
| Date Added to Maude | 2019-05-09 |
| 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. NICHOLE EARLY |
| Manufacturer Street | 9000 WESTMONT DRIVE STONEHOUSE COMMERCE PARK |
| Manufacturer City | TOANO VA 23168 |
| Manufacturer Country | US |
| Manufacturer Postal | 23168 |
| Manufacturer Phone | 8283387568 |
| Manufacturer G1 | AVID MEDICAL |
| Manufacturer Street | 9000 WESTMONT DRIVE STONEHOUSE COMMERCE PARK |
| Manufacturer City | TOANO VA 23168 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 23168 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCU-LINE |
| Generic Name | SURGICAL MARKING SYSTEM |
| Product Code | FZZ |
| Date Received | 2019-05-09 |
| Model Number | P-1RLNS |
| Catalog Number | P-1RLNS |
| Lot Number | 80109 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCU-LINE PRODUCTS INC. |
| Manufacturer Address | 379 IYANOUGH ROAD HYANNIS MA 02601 US 02601 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-09 |