MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-02-05 for KLING CONFORMING GAUZE BANDAGE, STERILE/PATIENT READY? 8137104143USA manufactured by Dukal/allmed.
[99037495]
Device was used for treatment, not diagnosis. Date of birth was not provided for reporting. (b)(4). Device is not expected to be returned for manufacturer review/investigation. A review of the device history records has been requested. If information is obtained that was not available for this medwatch, an additional follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[99037496]
Consumer experienced an allergic reaction and was administered prednisone as treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2018-00001 |
| MDR Report Key | 7241556 |
| Report Source | CONSUMER |
| Date Received | 2018-02-05 |
| Date of Report | 2018-02-24 |
| Date of Event | 2018-01-20 |
| Date Mfgr Received | 2018-02-24 |
| Device Manufacturer Date | 2010-06-08 |
| Date Added to Maude | 2018-02-05 |
| 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 | NI LINDA PLEWS |
| Manufacturer Street | 199 GRANDVIEW RD NI |
| Manufacturer City | SKILLMAN NJ 085589418 |
| Manufacturer Country | US |
| Manufacturer Postal | 085589418 |
| Manufacturer Phone | 2152737120 |
| Manufacturer G1 | DUKAL/ALLMED |
| Manufacturer Street | 19F, BLOCK A, TAURUS PLAZA NO. 8 TAOYUAN RD |
| Manufacturer City | SHENZHEN |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KLING CONFORMING GAUZE BANDAGE, STERILE/PATIENT READY? |
| Generic Name | JOHNSON & JOHNSON FIRST AID STERILE ROLLED GAUZE |
| Product Code | NAB |
| Date Received | 2018-02-05 |
| Model Number | 8137104143USA |
| Catalog Number | NI |
| Lot Number | 1590A |
| ID Number | (01)381371041435 |
| Device Expiration Date | 2013-06-07 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DUKAL/ALLMED |
| Manufacturer Address | 19F, BLOCK A, TAURUS PLAZA NO. 8 TAOYUAN RD SHENZHEN CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-02-05 |