MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2016-01-19 for BAB CLEAR WATER BLOCK PLUS 30S NI manufactured by Shanghai Johnson & Johnson Ltd..
[36235633]
This foreign report is being submitted on 19-jan-2016 for a device product that is considered same/similar to a us marketed device (bab clear water block plus 30s). This closes out this report unless additional significant information is received.
Patient Sequence No: 1, Text Type: N, H10
[36235634]
This spontaneous regulatory authority report was received on (b)(6) 2016 from (b)(6) (b)(4) reporting for an approximately (b)(6) male consumer from (b)(6). The medical history and the concomitant medications were not reported. On an unspecified date, the consumer started using band-aid clear waterblock 5 (route cutaneous, lot number 141204a 1217, expiration date, frequency and indication unspecified). After an unspecified duration, he developed anaphylactic reaction. After an unspecified duration, the device was discontinued. The outcome of event was unknown. This report was assessed as serious (medically significant). The company causality was assessed as related.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000599868-2016-00001 |
| MDR Report Key | 5375830 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2016-01-19 |
| Date of Report | 2016-01-04 |
| Date Mfgr Received | 2016-01-04 |
| Date Added to Maude | 2016-01-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NI JULIE THOMAS |
| Manufacturer Street | JOHNSON & JOHNSON CONSUMER INC 199 GRANDVIEW ROAD |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9082557895 |
| Manufacturer G1 | SHANGHAI JOHNSON & JOHNSON LTD. |
| Manufacturer Street | 120 NAN YA RD. MINHANG, NI |
| Manufacturer City | SHANGHAI 200245 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 200245 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NI |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAB CLEAR WATER BLOCK PLUS 30S |
| Generic Name | CLOSURE, WOUND, ADHESIVE |
| Product Code | MGO |
| Date Received | 2016-01-19 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | 141204A1217 |
| ID Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHANGHAI JOHNSON & JOHNSON LTD. |
| Manufacturer Address | 120 NAN YA RD. MINHANG, NI SHANGHAI 200245 CH 200245 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-01-19 |