MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-11 for MICRO TOUCH PLUS PF STYLE 530 manufactured by Siam Sempermed Corp Ltd.
[40123380]
Customer indicated that back of her hands were bleeding after wearing these gloves. She has worn these type of gloves for 35 years and never had a problem. Once she switched to nitrile gloves her hands got better
Patient Sequence No: 1, Text Type: D, B5
[42804989]
Sima sempermed corp. , ltd. , located in (b)(4) conducted a review of the device history record. The review indicated that the lot was in compliance with release criteria. Returned samples were tested for total protein content, ph, and powder residue with results within specification. From the testing, there was no indication for a cause of the cited reaction. Part of the returned samples were sent to an external testing lab for additional testing. Upon completion, results will be forwarded back to (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[42804990]
Customer indicated that back of her hands were bleeding after wearing these gloves. She has worn these type of gloves for 35 years and never had a problem. Once she switched to nitrile gloves her hands got better.
Patient Sequence No: 1, Text Type: D, B5
[47970967]
(b)(4) conducted a review of the device history record. The review indicated that the lot was in compliance with release criteria. Returned samples were tested for total protein content, ph, and powder residue with results within specification. From the testing, there was no indication for a cause of the cited reaction. Part of the returned samples were sent to an external testing lab for additional testing. Upon completion, results will be forwarded back to ansell. On 06/22/2016 update: an external lab analysis of the glove confirmed that the levels of anti oxidants and additives on the returned samples were within specification in comparison to historical data ((b)(4)).
Patient Sequence No: 1, Text Type: N, H10
[47970968]
Customer indicated that back of her hands were bleeding after wearing these gloves. She has worn these type of gloves for 35 years and never had a problem. Once she switched to nitrile gloves her hands got better on 06/22/2016 update: an external lab analysis of the glove confirmed that the levels of anti oxidants and additives on the returned samples were within specification in comparison to historical data ((b)(4)).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1019632-2016-00002 |
| MDR Report Key | 5494494 |
| Date Received | 2016-03-11 |
| Date of Report | 2016-06-22 |
| Date of Event | 2016-02-22 |
| Date Facility Aware | 2016-02-22 |
| Report Date | 2016-03-11 |
| Date Reported to FDA | 2016-03-11 |
| Date Reported to Mfgr | 2016-02-22 |
| Date Added to Maude | 2016-03-11 |
| 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 |
| 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 | MICRO TOUCH PLUS PF |
| Generic Name | MICRO TOUCH PLUS PF LATEX EXAMINATION GLOVE |
| Product Code | LYY |
| Date Received | 2016-03-11 |
| Model Number | STYLE 530 |
| Lot Number | 1503000977 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIAM SEMPERMED CORP LTD |
| Manufacturer Address | 10 SOI 10 PHETKASEM ROAD HATYAI SONGKHLA, 90110 TH 90110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-03-11 |