MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-28 for SKYN manufactured by Ids Manufacturing Co,.ltd.
[43925335]
Customer inquired "what complications could result from skyn long lasting lubricant, then oral consumption. Information required as i was hospitalized"
Patient Sequence No: 1, Text Type: D, B5
[46866876]
On june 9, 2016 - three attempts have been made to the customer (2 via email and 1 via mail) to get additional details on the incident with no response from the customer. Manufacturer can provide no comment on the device at this time without such details.
Patient Sequence No: 1, Text Type: N, H10
[46866877]
Customer inquired "what complications could result from skyn long lasting lubricant, then oral consumption. Information required as i was hospitalized" (b)(6) 2016 - customer contact has been attempted three time (2 times by email and 1 by letter) with no response. Manufacturer can provide no additional detail at this time.
Patient Sequence No: 1, Text Type: D, B5
[47940900]
June 9, 2016 - three attempts have been made to the customer (2 via email and 1 via mail) to get additional details on the incident with no response from the customer. Manufacturer can provide no comment on the device at this time without such details. June 22, 2016 - a review of the product safety report for the original device indicated the materials in question have a very low acute oral toxicity profile. Product biocompatibility evaluations at the time indicated no issue. This notice serves as the final update on this report ((b)(4)).
Patient Sequence No: 1, Text Type: N, H10
[47940901]
Customer inquired "what complications could result from skyn long lasting lubricant, then oral consumption. Information required as i was hospitalized. " june 9, 2016 - customer contact has been attempted three time (2 times by email and 1 by letter) with no response. Manufacturer can provide no additional detail at this time. June 22, 2016 - a review of the product safety report for the original device indicated the materials in question have a very low acute oral toxicity profile. Product biocompatibility evaluations at the time indicated no issue. This notice serves as the final update on this report ((b)(4)).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1019632-2016-00003 |
| MDR Report Key | 5616447 |
| Date Received | 2016-04-28 |
| Date of Report | 2016-06-22 |
| Date of Event | 2016-04-25 |
| Date Facility Aware | 2016-04-25 |
| Report Date | 2016-04-28 |
| Date Reported to FDA | 2016-04-28 |
| Date Reported to Mfgr | 2016-04-28 |
| Date Added to Maude | 2016-04-28 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKYN |
| Generic Name | PERSONAL LUBRICANT |
| Product Code | NUC |
| Date Received | 2016-04-28 |
| Lot Number | 15011501DR |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IDS MANUFACTURING CO,.LTD |
| Manufacturer Address | 21/7 LIABKWANGSONG VILLAGE NO 6 LAMLUKKA PATHUM THANI, SUB DIST KOOTKOT 12130 TH 12130 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-04-28 |