MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-31 for JOHNSON & JOHNSON COACH SELF-ADHERING SPORTS WRAP 381370079293 manufactured by Caremax.
[109898202]
Device was used for treatment, not diagnosis. (b)(4). Expiration date = na lot number = (10)2867car device is not expected to be returned for manufacturer review/investigation. Concomitant medical products and therapy dates: drug: alprazolam 1 mg; 2 a day; unknown timeframe; for anxiety; consumer still on drug food: b-12 2500mcg; 1 x daily; unknown timeframe; for general health; consumer still using food: d- 3 gummies 50mcg; 2 a day; unknown timeframe, for general health; consumer still using drug: escitalopram; 2 x daily; unknown timeframe; for depression; consumer still on drug drug: levothyroxine 50 mcg; 1 a day; unknown timeframe; for hypothyroidism; consumer still on drug : nexium; 1 a day; unknown timeframe; for stomach acid and irritable bowel; consumer still on drug food: vitamin c gummies; unknown dosage; unknown timeframe; for general health; consumer still using food: biotin 1000mcg; 1 a day; unknown timeframe; for hair health; consumer still using a review of the device history records has been requested. Device evaluation/investigation could not be completed; no conclusion could be drawn at this time as product was not returned to manufacturer. (b)(4) labeling design - part of recall number z-1202-2018 if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[109898203]
This incident involves a (b)(6) female consumer using a coach self adhering sports wrap. On (b)(6) 2018, the consumer reported using a coach self adhering sports wrap to cover a ringworm site. She noted she had itching from using the coach self adhering sports wrap. The consumer indicated she left the coach self adhering sports wrap on for an unknown time and that she had itching before she applied the product. The consumer stated she has an allergy to latex and did not know if the coach self adhering sports wrap product was causing additional itching. She did not treat the event and did not know the exact date that she started using or discontinued use of the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2018-00009 |
| MDR Report Key | 7557959 |
| Date Received | 2018-05-31 |
| Date of Report | 2018-06-08 |
| Date Mfgr Received | 2018-06-08 |
| Device Manufacturer Date | 2017-10-13 |
| Date Added to Maude | 2018-05-31 |
| 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 | LINDA PLEWS |
| Manufacturer Street | 199 GRANDVIEW RD |
| Manufacturer City | SKILLMAN NJ 085589418 |
| Manufacturer Country | US |
| Manufacturer Postal | 085589418 |
| Manufacturer Phone | 2152737120 |
| Manufacturer G1 | CAREMAX |
| Manufacturer Street | NO. 43, SHUANG JING STREET FENG TING RD |
| Manufacturer City | SIP, JIANGSU, P.R. 215121 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 215121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | Z1202-2018 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | JOHNSON & JOHNSON COACH SELF-ADHERING SPORTS WRAP |
| Generic Name | WRAP, STERILIZATION |
| Product Code | FRG |
| Date Received | 2018-05-31 |
| Model Number | 381370079293 |
| Lot Number | 2867CAR |
| ID Number | (01)381370079293 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREMAX |
| Manufacturer Address | NO. 43, SHUANG JING STREET FENG TING RD SIP, JIANGSU, P.R. 215121 CH 215121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-31 |