MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-29 for SKIN MARKER 26-002 manufactured by Private Label Products, Inc..
[129681895]
Investigation summary: an internal complaint ((b)(4)) was received indicating that a patient had an allergic reaction following the use of a skin marker (part 26-002, lot 45438161) in a surgery. A sample was initially reported to be available for return. However, as of the date of this report, a sample has not been returned. This product has undergone primary skin irritation and buehler sensitization testing in its final, finished form. The results for both tests met the requirements of the standard. The work order for the reported lot was reviewed for discrepancies that may have contributed to the reported issue. One defect for a dirty product was found and documented. The skin marker is supplied to deroyal by private label products. A supplier corrective action request was issued november 2, 2018, to private label products. As of the date of this report, a response has not been received. Deroyal has sold (b)(4) cases of the finished good from 2016 to 2018. Each case contains 50 each, which equates to a total of (b)(4) "eaches" sold. Internal complaints were reviewed for the same time period. No complaints were identified for the same issue that was reported in this incident. This results in a sales-to-complaint ratio of (b)(4). The investigation is ongoing at this time. If new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[129681896]
An end user reported an incident of allergic reaction right after surgery. A type 1 response and type 4 response were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1060680-2018-00009 |
| MDR Report Key | 8116867 |
| Date Received | 2018-11-29 |
| Date of Report | 2019-02-05 |
| Date of Event | 2018-11-01 |
| Date Mfgr Received | 2018-11-01 |
| Date Added to Maude | 2018-11-29 |
| 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 | SARAH BENNETT |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626112 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | 1703 HIGHWAY 33 SOUTH |
| Manufacturer City | NEW TAZEWELL TN 37825 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37825 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SKIN MARKER |
| Generic Name | MARKER, SKIN |
| Product Code | FZZ |
| Date Received | 2018-11-29 |
| Returned To Mfg | 2018-12-07 |
| Model Number | 26-002 |
| Lot Number | 45438161 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRIVATE LABEL PRODUCTS, INC. |
| Manufacturer Address | 20-21 WAGARAW ROAD BUILDING 34 FAIR LAWN NJ 07410 US 07410 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-29 |