MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-03-11 for 3M? NEXCARE? WATERPROOF BANDAGES N/A 432-50 manufactured by 3m Health Care.
[138440071]
Age or date of birth, weight, ethnicity, race: this information was not provided. Lot #, expiration date: lot # provided was 186935rev-01. This is not a valid lot code; therefore, expire date unknown. Clear waterproof bandages have a 5 years shelf life. Reporter: initial reporter's full physical address and email address was not provided. Occupation: initial reporter's occupation was not specified. Manufacture date: a valid lot # was not provided; therefore, manufacture date is unknown. The device has been not returned for evaluation, though requested by 3m. Complaint history for the last 24 months was reviewed for the defined failure code for the product's global sales code (gsc) of sxj. No trends were observed. The product will be evaluated and a follow up report will be submitted if product is received.
Patient Sequence No: 1, Text Type: N, H10
[138440072]
A female customer (age not specified) applied the referenced bandages to her left cheek to cover a surgery wound. The woman applied the bandages to cover the partially healed wound while going into water. The bandages were used for a couple of weeks. Bandage adhesive placement was not rotated during application. No ointment or creams were being applied to the wound site. On (b)(6) 2019, the woman alleged noticing her skin underneath the bandage was bright red upon removal. She reported the bandage was removed gently. The reddened skin was reported to be in the shape of the bandage adhesive. No bumps were present. No known allergies were specified. The woman discontinued use of the bandages. The woman alleged the skin surrounding the bandage application area developed a bright red rash which spread. She consulted a dermatologist on an unspecified date. The dermatologist recommended hydrocortisone 2. 5% topical be applied over the affected area. On (b)(6) 2019, the woman reported the affected area was clearing up with one day remaining on prescribed hydrocortisone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2019-00034 |
| MDR Report Key | 8409476 |
| Report Source | CONSUMER |
| Date Received | 2019-03-11 |
| Date of Report | 2019-04-02 |
| Date of Event | 2019-02-07 |
| Date Mfgr Received | 2019-03-14 |
| Date Added to Maude | 2019-03-11 |
| 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 | MR. BRYAN BECKER |
| Manufacturer Street | 2510 CONWAY AVENUE |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517375578 |
| Manufacturer G1 | 3M HUTCHINSON |
| Manufacturer Street | 905 ADAMS STREET SE |
| Manufacturer City | HUTCHINSON MN 55350 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55350 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M? NEXCARE? WATERPROOF BANDAGES |
| Generic Name | TAPE AND BANDAGE, ADHESIVE |
| Product Code | KGX |
| Date Received | 2019-03-11 |
| Returned To Mfg | 2019-03-11 |
| Model Number | N/A |
| Catalog Number | 432-50 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVENUE ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-03-11 |