MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-05-13 for BAND-AID BRAND PLASTIC COMFORT FLEX BANDAGES 8137005635 manufactured by Brazil Consumer.
[3505417]
This spontaneous report was received on (b)(4) 2013, from a female consumer (age unspecified) reporting on self from the unites states. The consumer was allergic to trees, mosquitoes, carrots and dairy products. The concomitant medications were not reported. On an unspecified date, about two weeks ago, the consumer started using band aid brand plastic comfort flex bandages, cutaneously twice and changed the band aid every ten minutes, to cover scrapes on forehead and nose (lot number 2502b and expiration date unspecified). After an unspecified duration, following the removal of the bandage, her skin and scab came off. She also noticed the gauze of the bandages was thin and hard. She consulted a health care professional and treated the event by applying an triple antibiotic (neomycin, polymyxin b, and bacitracin). About two weeks before reporting, she was hospitalized for two days and had laboratory tests done, as the physician mentioned that six layers of her skin had been removed. After an unspecified duration, she discontinued the use of the device. The event was resolving. This report was assessed as serious (hospitalisation). The company causality was assessed as possible. This report was considered a non reportable malfunction in the united states.
Patient Sequence No: 1, Text Type: D, B5
[10759638]
(b)(4). This closes out this report unless other additional significant information is received.
Patient Sequence No: 1, Text Type: N, H10
[15023347]
This spontaneous report was received on (b)(6) 2013, from a female consumer (age unspecified) reporting on self from the unites states. The consumer was allergic to trees, mosquitoes, carrots and dairy products. The concomitant medications were not reported. On an unspecified date, about two weeks ago, the consumer started using band aid brand plastic comfort flex bandages, cutaneously twice and changed the band aid every ten minutes, to cover scrapes on forehead and nose (lot number 2502b and expiration date unspecified). After an unspecified duration, following the removal of the bandage, her skin and scab came off. She also noticed the gauze of the bandages was thin and hard. She consulted a health care professional and treated the event by applying an triple antibiotic (neomycin, polymyxin b, and bacitracin). About two weeks before reporting, she was hospitalized for two days and had laboratory tests done, as the physician mentioned that six layers of her skin had been removed. After an unspecified duration, she discontinued the use of the device. The event was resolving. This report was assessed as serious (hospitalisation). The company causality was assessed as possible. This report was considered a non reportable malfunction in the united states. Additional information received on (b)(6) 2013: a batch record review disclosed that all processes in place at time of manufacturing met specifications and no abnormalities were found. Review of related product changes including all related design/formula, packaging/labeling changes and manufacturing/facility issues including review of related facility non-conformances/deviations from (b)(6) revealed no issues or deviations. Visual inspection of retain sample revealed no deviations and appeared to be typical of the product. The field sample has not been received. A review of the complaint data revealed no adverse trends and no trends involving this lot number. This complaint could not be confirmed based on an acceptable site review and no adverse trends. Root cause and disposition were undetermined. Complaint trends would continue to be monitored. This report remains as serious (hospitalization). This report remains a non reportable malfunction in the united states.
Patient Sequence No: 1, Text Type: D, B5
[15420715]
The date of this submission is (b)(4) 2013. This closes out this report unless other additional significant information is received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2214133-2013-00044 |
| MDR Report Key | 3108428 |
| Report Source | 04 |
| Date Received | 2013-05-13 |
| Date of Report | 2013-04-19 |
| Date Mfgr Received | 2013-05-27 |
| Date Added to Maude | 2013-05-13 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MS. AMAL YAMANY |
| Manufacturer Street | 199 GRANDVIEW ROAD NI |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089043455 |
| Manufacturer G1 | BRAZIL CONSUMER |
| Manufacturer Street | RODOVIA PRESIDENTE DUTRA KM 15 NI |
| Manufacturer City | S NI |
| Manufacturer Country | BR |
| Manufacturer Postal Code | NI |
| Single Use | 0 |
| Previous Use Code | 3 |
| Removal Correction Number | NI |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAND-AID BRAND PLASTIC COMFORT FLEX BANDAGES |
| Generic Name | DRESSING, WOUND, OCCLUSIVE |
| Product Code | FPX |
| Date Received | 2013-05-13 |
| Model Number | 8137005635 |
| Catalog Number | NI |
| Lot Number | 2502B |
| ID Number | NI |
| 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 | BRAZIL CONSUMER |
| Manufacturer Address | RODOVIA PRESIDENTE DUTRA KM 15 NI S?O JOS? DOS CAMPOS NI BR NI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-05-13 |