MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-23 for STRENGTH TAPE 6300-SHLDR manufactured by Suzhou Sunmed Co Ltd.
[60843592]
A customer called on (b)(6) 2016 to report having an allergic reaction to a strengthtape shoulder kit, item number 6300-shldr. The customer noticed the irritation within 2 hours of using the tape. The customer had a similar reaction to the adhesive in a nicotine patch about 8 years prior to this. The customer had been using kinesio tape for the past few months, which was removed about 2-3 days prior to applying the strengthtape.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2016-00002 |
| MDR Report Key | 6125771 |
| Date Received | 2016-11-23 |
| Date of Report | 2016-11-23 |
| Date of Event | 2016-10-31 |
| Date Facility Aware | 2016-10-31 |
| Report Date | 2016-11-23 |
| Date Reported to FDA | 2016-11-23 |
| Date Reported to Mfgr | 2016-11-23 |
| Date Added to Maude | 2016-11-23 |
| 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 | STRENGTH TAPE |
| Generic Name | ORTHOPEDIC TAPE |
| Product Code | HXT |
| Date Received | 2016-11-23 |
| Model Number | 6300-SHLDR |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUZHOU SUNMED CO LTD |
| Manufacturer Address | NO.88 SHISHAN ROAD SUZHOU CITY, JIANGSU 215011 CH 215011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-11-23 |